Regulatory Affairs Project Manager Job – Medical Device
Our client needs a Regulatory Affairs Project Manager to support Asia Pacific (Japan, China, South Korea and Taiwan) regulatory approvals for implantables. Comfort and experience working hands on with design and validation reports and other technical files is needed.
Previous experience authoring or approving design and validation reports a plus (strong technical writing skills).
Experience in Regulatory Affairs with US Class III cardiovascular devices strongly preferred.
Experience working with registration partners.
510(k) experience and PMA experience a plus.
The Regulatory Affairs Project Manager will report to the Manager of International Regulatory Affairs.
Manage the preparation and maintenance of high quality filings to clearly documented, established timelines, including but not limited to: Letters to File (LTFs); investigational use applications and annual reports; marketing applications and annual reports to US and international regulatory authorities.
Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensure effective communication to the project teams and management.
In conjunction with international regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals in identified regions globally.
In collaboration with the international regulatory team, manage interactions with international agents and distributors to clearly identify regulatory requirements and changes on an ongoing basis.
Directly interact with regulatory bodies in the US and internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate.
Review and approve document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents as a key member of the project teams.
Manage query resolution process using sound project management skills and to agreed upon timelines in collaboration with cross-functional technical teams.
Coordinates with RA international staff and internal support staff to support basic file preparation as needed.
Update departmental procedures
Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication.
The Regulatory Affairs Project Manager title is equivalent to the Principal Regulatory Specialist title.
We have a medical monitor oncology job for a doctor with experience in clinical drug development. The doctor will help our foreign-based client with their US clinical trials. Work is estimated to take 20 hours per month to start.
Medical Doctorate (MD) or equivalent
5 years clinical drug development experience in oncology
Phase 1 and phase 2 studies
1. Available to clinical investigator sites as a go-to person in the US for checking eligibility
2. Be responsible for interacting with sites on safety management of the study. This will include but not limited to evaluation of serious adverse events, adverse events of special interest, discussions with sites on causality assessments, requesting clarifications on safety data and ensuring that information collected in the prescribed forms or data bases is complete.
Global Pharmaceutical Labeling Manager – Contract position in Irvine CA
Our client needs a Contractor to work as Manager of Global Pharmaceutical Labeling. Contract is estimated for 12 months at their facility in Irvine, CA. Possibility for conversion to full-time after a year. We offer benefits including employer contribution to healthcare for this position. You must have authorization to work in the United States (sponsorship is not available).
Requirements – Must Have!
Bachelor’s degree in a related scientific discipline with a minimum of 4 years related experience within a pharmaceutical company, CRO or similar organization.
Or Masters, PharmD or PhD with minimum of 2 years’ experience.
Experience drafting and reviewing pharmaceutical labeling and compiling supportive documentation, and demonstrated competence in marketed product labeling maintenance.
Live within commuting distance to Irvine, CA
Basic knowledge of global core data sheet guidance and US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
Detail-oriented, well organized and good planning skills.
Ability to manage multiple projects and deadlines.
Ability to exercise independent judgment yet identify compliance risks and escalate whennecessary.
Excellent proofreading/editing skills are required
Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
Excellent computer skills required
Main Areas of Responsibilities
Facilitate Core Pharmaceutical Labeling Review Committee and US Labeling Review Committee meetings for assigned marketed or development product, ensuring the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes and follow-up of action items to complete resolution. Provide strategic Labeling guidance to authors regarding appropriate content for Company Core Data Sheets, FDA regulations, and FDA guidance.
Assist in the development and review of international local labeling in accordance with the Company Core Data Sheet
Interact with business partners and provide strategic guidance as appropriate to ensure consistency and compliance of product labeling.
Manage outside vendor conversion of package inserts from MS Word or PDF to SPL format. Convert existing package inserts into Physician Labeling Rule (PLR) format, as needed.
Coordinate preparation of regulatory labeling submissions initiated by Regulatory Affairs with contributing functions in other departments.
Review for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the Project Teams or Regulatory Strategists as appropriate.
Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
Assist with training of Regulatory Affairs and other functions re: labeling processes as appropriate.
Maintain knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.
Boutique search agency in Glendale, CA seeks hiring for the first of multiple Human Resource Accounting Assistant job openings. We need someone part time who can become full time as we fulfill the needs of new clients.
Both: 1-2 years experience in Human Resources and 1-2 years experience in Accounting QuickBooks
BA/BS degree preferred
• Human Resources: Assist in processing new hire paperwork; employee benefits, insurance and taxes; liaison to all internal and external employees
• Accounting/Payroll: A/P, A/R, payroll, taxes, quarterly and year-end reports; reconcile invoices and statements; scan and electronically file documents; working knowledge of Quick Books, Adobe Acrobat, Outlook, Word and Excel
• Other duties as assigned: process government reports (we have Federal and State funding), grants and GSA contracts
• Candidates living within 5 miles of the City of Glendale are preferred
Pay and Benefits
Base dependent on work experience and references
Full time benefits: medical insurance, paid time off, paid holidays, discretionary merit bonuses
Your Staffing contractors now have general liability insurance for up to $10 million
We have increased our general liability insurance coverage for contractors, temps and temps to hire from $2 million to $10 million to better serve our customers. Additionally, we are carrying an additional $2 million for Errors and Omissions – after all there is nothing more expensive than bad data.
One of the pitfalls to hiring a 1099 contractor is that most likely, they do not have general liability insurance,which protects you, their client, and ensures their business continuity. Should they inadvertently damage your equipment or data, you will have to make a claim against your own insurance policy, if possible.
What is General Liability Insurance
General Liability Insurance is a part of the general insurance system of risk financing to protect the purchaser (the “insured”) from the risks of liabilities imposed by lawsuits and similar claims. It protects the insured in the event he or she is sued for claims that come within the coverage of the insurance policy.General liability insurance covers negligence, property damages, personal injury, advertising injury, electronic data, defense costs and possible loss of business.
Make sure your 1099s have insurance by putting them on a staffing contract through us. They will get W2s, be eligible for benefits and be covered under workers’ compensation. This will also help avoid an Employment Development Department (EDD) Audit.
FSPCA FSMA Training, June 2017, Cal Poly, Pomona, CA
Four reasons to take FSPCA FSMA Training:
FDA requires food companies with more than $1M in revenues have a plan by September 19, 2017
Plans must be signed off by someone with a FSPCA certificate
Writing a plan is a 5-6 month process
The learning manual is 526 pages long
Avoid getting into compliance too late.
Attendees of our March FSMA training at NOAA
bfor Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through our Foundation and hosted by Cal Poly Pomona. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.
WHEN Wednesday, June 21, 2017 at 7:30 AM – Friday, June 23, 2017 at 1:00 PM (PDT)
Our client needs a full-time Senior GVP Audit/Project Manager to handle their GVP Pharmacovigilance Audits. This person will plan and perform domestic and international GVP audits to assess the company’s compliance to local and international government regulations. They will also assess internal SOPs as they relate to GVP Quality Assurance and regulatory compliance. This position is located Read the rest of this entry »
Avoiding an Employment Development Department Audit
The Employment Development Department (EDD) conducts payroll tax audits of businesses operating in California. Here are some triggers that cause a company to get audited:
The 1099 independent contractor (IC) files an unemployment claim. This creates suspicion because ICs are NOT eligible for unemployment.
The 1099 IC files a workers’ compensation or disability claim against the company. If someone is truly an IC, they should carry workers’ comp and disability insurance on themselves because they are not eligible through an employer.
A worker receives a W-2 and a 1099 Form from the same employer in one year. This happens when they are converted from a 1099 IC to a direct hire of the company. But if they performed the same work as a 1099 IC and a W-2 employee, the IRS may wonder why they were not classified as an employee all along. Read the rest of this entry »
Clinical Operation Manager Needed, Remote / Work from Home
Clinical Operation Manager needed by our client to co-ordinate clinical study design and implementation at a program and functional level according to Good clinical practice (GCP).
Clinical Operation Manager Qualifications
Position requires a minimum of a Bachelor of Science degree and at least 5 years of clinical study management experience, including at least 2 years of phase III study management experience (7 years of clinical management experience for Sr. Manager or graduate level education with at least 3 years of clinical study management experience) in clinical research within a pharmaceutical or biotech environment or relevant CRO experience.
Experience working in therapeutic areas in ophthalmology will be a plus.
Good understanding of clinical study implementation process.
Willingness to travel up to 30%, as necessary, consistent with study or functional needs.
Our client is in need of an experienced oncology medical writer. The medical writer will translate the scientific hypotheses of clinical trials into lay terms for patient population and patient navigators. Ideally, you have experience in consumer-facing communication.
QA Engineer – Medical Devices & IVD Manufacturer, Los Angeles, CA
QA Engineer needed to manage the selection, qualification, and monitoring of suppliers including finished device, OEM, and contract manufacturers. This person will play a key role in working with suppliers to resolve quality issues (SCAPAs), resolving internal non-conforming product issues, addressing incoming inspection challenges, including development and review of inspection procedures, overseeing equipment calibration, maintenance and validation, and maintaining accurate and complete documentation of these activities in compliance with the requirements of the Quality System Regulation (21 CFR 820) and ISO 13485.
B.S. in in a technical discipline (i.e. science or engineering)
Five or more years of relevant experience in an FDA regulated industry
3-5 years of which is in Quality Assurance
ASQ Certification as Quality Engineer (CQE) or equivalent, preferred
FSPCA FSMA Training for Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through our Foundation and hosted by Rentokil North American. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.
WHEN Wednesday, March 22nd, 2017 at 7:30 AM – Friday, March 24, 2017 at 1:00 PM (PDT)
WHERE: Rentokil, China Lake Training Room, 305 N. Crescent Way, Anaheim, CA 92801- View Map
Laboratory Assistant – Medical Devices & IVD Manufacturer, Los Angeles, CA
Laboratory Assistant needed to perform routine equipment maintenance, assure adequate stock and labeling of laboratory reagents and consumables, manage chemical and biological waste, sanitize lab surfaces, and monitor environmental controls.
B.S. in Chemistry, molecular biology or biological sciences
1-4 years hands-on experience in a regulated, laboratory environment
Knowledge of GLP, CLIA and HIPAA regulations governing handling and testing of patient samples in a clinical lab
Knowledge of safety precautions required for working with blood borne pathogens
Medical background preferred which includes medical terminology applicable to a clinical laboratory
VP Clinical Development – Rare and Orphan Diseases
VP Clinical Development for a small clinical-stage pharma company in Los Angeles San Fernando Valley. Candidate needs to have a MD, be experienced in rare and orphan disease studies and have significant experience clinical trials.
M.D. or D.O. with specialty training, preferably CNS diseases
10 -15 years of progressive experience through all the phases of drug development would be ideal
Management of clinical trials (Phases 1 – 3)
Experience in orphan and rare diseases, pediatrics and/or neurology preferred
VP Genomic Research needed to manage operational and logistical tasks of genomic test development to ensure efficient execution of studies for molecular diagnostic products within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations. The candidate will be responsible for designing the test development process, directing a team of molecular biologist, computational biologists, and clinical scientists. Read the rest of this entry »
Director of IVD Manufacturing and Supply Chain needed for an in-vitro diagnostics (IVD) client in Los Angeles, CA. The role is responsible for working with Product Development to select and manage key suppliers. Work alongside management and sales to establish forecasts and delivery schedules for key materials. This role will also negotiate Supply Contracts and assist in Read the rest of this entry »
VP Clinical Affairs needed to develop and implement clinical studies and molecular diagnostics validation strategy. The VP will coordinate the efforts of internal and external resources to ensure fast patient recruitment, trial site selection, trial plan optimization, and execution of trials with a focus on data quality. The candidate must be Read the rest of this entry »
Preventive Controls Training (PCQI) for Human Foods CFR 21 Part 117
Preventive Controls Training for Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through our Foundation in addition to the Port of Los Angeles and the National Oceanic and Atmospheric Administration. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.
WHEN Wednesday, February 22nd, 2017 at 7:30 AM – Friday, February 24, 2017 at 1:00 PM (PDT)
Whether you are interested in finding talent to build your quality team, or interested in advancing your own career in Quality, feel free to link to Rosemarie or Lewie and Read the rest of this entry »
This was my first time attending the ASQ -FDC -PDA -SoCalBio joint networking event on 6 October 2016 in beautiful Irvine, California. The event was introduced by Ruchika Raval (PDA), Brian Underhill (SoCalBio) and event moderator Michael Hamrell. This was followed by the speakers and panel members: Marlene Garcia Swider, Barbara Uger, and Susan Bain, sparked Read the rest of this entry »
The Top 25 biotech companies have convoluted career sites. It is frequently difficult to find where to search jobs and often more complicated than it needs to be.
Career Search All of Them at Once
Genetic Engineering and Biotechnology News (GEN) published a list of the Top 25 Biotech companies. Their list is based on total market capitalization. Interested in searching for your next job at these top companies? Use our search engine below. It only includes career pages of the companies that made GEN’s list*. Read the rest of this entry »
ASQ CHA Review Workshop is scheduled for Friday, September 30, 2016 from 7:30 AM to 5:00 PM (PDT) at USDC NOAA Office of International Affairs and Seafood Inspection, 501 West Ocean Blvd, Long Beach CA
About the Workshop
The Bureau of Labor Statistics published its first Data on Certificates and Licenses. They note that those who hold a license or certification earn one-third more than those who do not. And holders are less likely to be unemployed.
If you are ready to take the next step in your quality career consider becoming a Certified HACCP Auditor (CHA) . Come and join us for a full day CHA/CQIA Exam Review Workshop for only $99! Read the rest of this entry »
Money flows into life sciences appears to be on the rise.
This past February’s Biotech crash had a ripple effect for many companies. For example, following the crash, clinical trial starts dipped. This is according to CRO Activity Report 2Q 2016 report issued by BioPharm Insight. As an Executive Search firm with an eye out for opportunities where our candidates can make a big difference in pushing science (and investor returns) forward, this downturn has been disconcerting. Read the rest of this entry »
FSMA Preventive Controls for Human Foods CFR 21 Part 117
FSMA Preventive Controls for Human Foods is a 5-week class offered at Miramar college starting Wednesday, October 5th from 9am-2pm. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.
WHEN Wednesday, October 19, 2016 at 9:00 AM – Wednesday, November 16, 2016 at 1:00 PM (PDT)
WHERE San Diego Miramar College – 10440 Black Mountain Road, San Diego, CA 92126 – View Map
Earn a Certificate of Training from Food Safety Preventive Controls Alliance
It has been more than 6 years since the final implementation of 21CFR Part 111. We continue to see warning letters issued by the FDA to the industry for non compliance with the regulations.
This is a clear indication that there is still a need for better understanding of the regulations and alignment between the agency and the industry. And now we have FSMA (Food Safety Modernization Act), signed into law by President Obama in January 4, 2011. FSMA Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in Read the rest of this entry »
An Oncology Research Nurse is needed by our client in Santa Monica, CA. Candidate should have experience in Oncology and wants grow by serving patients enrolled in clinical trials. Read the rest of this entry »
Business Development / Sales -Cardio Medical Devices
Business Development, Sales Manager, or Account Manager with more than 5 years of experience selling to the cardiovascular medical device industry needed. The position calls for someone to sell auditing and testing services to medical device companies. The candidate should demonstrate they have built a book of business within the medical device industry and increased revenues. Read the rest of this entry »
Clinical Research Services help optimize your development timelines, whether your company is developing a biologic, drug or medical device. We offer a range of services to help you achieve your objectives.
CE marking approval in Europe is being influenced by new regulations. These medical device regulations are replacing the current CE requirements outlined in medical device directives that dictate how your product achieves a CE mark.
Staffing agency fees include base pay, taxes, benefits and overhead.
Using data from March 2016, the Bureau of Labor Statistics (BLS), the average US employee earned earned $23.25 per hour. Employee benefits cost employers $10.70 per hour for a total of $33.94 per hour.
Staffing agencies usually quote their fees as a multiplier of the employee’s base pay. The BLS data demonstrates that the first 1.46 of staffing agency fees covers wages, taxes and benefits ($33.94/$23.25 = 1.4597).
Biotechnology careers include your long-term goals. You can manage this journey through a combination of education, certifications and experience. Only then can you arrive at the destination you are most interested in.
Biotechnology jobs includeClinical Trials, Clinical Research, Quality, Regulatory, and Medical Affairs, Engineering and Software. Research in food, pharmaceuticals, biologics, and medical devices are sometimes lumped in with biotechnology.
Rx Research Services receives US Department of Labor Certificate of Registration of Apprenticeship Program
Mentor Mas Hori and his Food Safety Apprentice Karnia
(May 30, 2016 Los Angeles, CA) STEM apprentices to get on the job training and employment as Microbiology Quality Control Technician Quality Control Technician, Regulatory Compliance Associates plus 6 more Apprenticeships in food and biotechnology industries
Commercial Development Director / Sales (East Coast, West Coast, Europe)
The Commercial Development Director will set a road map for the sales team. The client is a Contract Manufacturer that provides bulk drug formulation and manufacturing. They also provide primary and secondary packaging capabilities for solid dose drugs. Their technologies include granulation, coating, blending, encapsulation, compression and drying of tablets and capsules.
Bachelor’s Degree Science/Business
Five plus years of selling in the Contract Manufacturing market
Lab Apprentices —Building a Workforce in a Tight Labor Market
Lab Apprentices are now available for CLIA, CAP and 17025 labs in California.
“We are pleased with [our apprentice] who has been valuable to effectively upgrade our quality control programs, bring a youthful vision and spirit to our workforce, and help us develop a competent team for the future,” said Kevin Kimura of Red Shell Foods, Inc. in Sante Fe Springs, CA.
We are hoping to bring the same satisfaction our food companies have to labs.
You only get one first impression. Skype has become the first impression that employers get of candidates. These interviews are being used it to whittle down the candidate pool for face to face interviews.
Clinical research staffing agencies cut the time for your clinical trials to succeed
Clinical research staffing agencies like MEIRxRS reduce your employment costs, reduce risk and increase flexibility.
Because balancing the demands of both your investors and FDA regulators isn’t easy.
We reduce your employment costs by allowing you to only pay for the skill set you need, with very little training or ramp-up time. And our thorough search process will ensure we find the talent required for your clinical trials to produce high-quality results for FDA approval.
Startup Incubator Labs are a great place for founders to build their pharma, biotech or medical device company. We’ve built a list of area labs for you. If you’re thinking to start your own business, looking to network with or do business with local startups use this list to find an incubator that’s Read the rest of this entry »
Clinical Project Manager (Part-Time Contract ) – Philadelphia, PA
A Clinical Project Manager (part time contract) is needed for a Contract Research Organization (CRO) to work in their office in the Philadelphia area. This position will report directly to the Chief Medical Officer and includes responsibility for coordinating and managing all aspects of clinical study activities to maintain regulatory compliance and meet company timelines and goals for the clinical development program. Looking for Read the rest of this entry »