April 28th, 2017

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.

Requirements

  • 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.

Major Duties

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.

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Contact Paul/Submit Your Resume

Paul Dionne
Talent Manager
MEIRxRS
pdionne@meirxrs.com 818-552-2625

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