Regulatory Affairs Associate Drug Device Combo, 12 weeks in Pleasanton, CA
Regulatory Affairs Associate Drug Device Combo, 12 weeks in Pleasanton,CA
Our large drug/device combo client in Pleasanton, CA needs a temporary Regulatory Affairs Associate. This contract is estimated to last 12 weeks. This person will coordinate most aspects of company regulatory activities and may interface with domestic and international health authorities.
• BS or BA degree, 1-3 years of experience in regulatory affairs.
• Experience in a company start-up environment, preferably in medical devices or combination products.
• Knowledge of FDA, CA-FDB, and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).
• RAC certification in US, EU, and/or CAN is a plus.
• Ability to focus on and achieve scheduled milestones, including contingency planning.
• Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
• Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Regulatory Affairs Associate Duties and Responsibilities
• Assists in the development and deployment of the regulatory program that ensures aggressive product approval, adoption within the international standard ISO13485; 21 CFR 803, 806, and 820; the current Canadian Medical Device Regulations (SOR 980282); Medical Device Directive 93/42/EEC (and all applicable amendments); MHLW Ordinance No 169 and other applicable regulations and guidelines in accordance with corporate objectives.
• Generates and coordinates regulatory submission documents for new products or changes to existing health authorities’ filings.
• Writes, submits, and coordinates new product notifications, CE Mark Technical Files/Dossiers, Investigational Device Exemptions and international regulatory submissions in various countries.
• Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance.
• Partners with various teams throughout organization (Marketing, Promotions, Operations, R&D, Quality, etc.) on projects.
• Acts as team expert for promotional materials review, experimental designs, data analysis, and product labeling as they relate to registration and commercialization of devices.
• Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations.
• Determines international regulatory requirements and develops plans to comply with national laws in each country.
• Assists with the management and execution process for international registrations including providing guidance with localization and labeling requirements.
• Works with Customer Service team with complaint handling, analysis and regulatory reporting requirements (US and international).
• Participates as needed in field actions including assisting with the creation of plans and reports, action execution, and regulatory agency interaction.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which company complies.
The Regulatory Affairs Associate may perform other related duties as assigned.
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