Regulatory Affairs Manager at TalentBurst, an Inc 5000 company

Regulatory Affairs Manager

St. Paul MN

6 Months

Regulatory Affairs Project Manager (Individual Contributor Role)

This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

Provides regulatory affairs project management for various areas, to include regulatory submissions for new products, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets.

Co-ordinates preparation of well organized, complete and scientifically sound regulatory submissions. Interfaces directly with various regulatory agencies, as required, to facilitate the timely review and approval of regulatory applications. Responsible for filing necessary applications and handling government interactions pertaining to the regulation process for products requiring regulatory approval.

Provides guidance on regulatory requirements and strategies to product development project teams. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Exercises judgement within generally defined practices and departmental standard operating procedures. Maintain expert working knowledge of relevant laws, regulations and enforcement decisions.

Knowledge of EU MDR requirements and other applicable EU regulations as they relate to Class III implantable medical devices. Authors and submits clinical trial applications under EUMDR and applications for CE mark. Proven successful track record of authoring/submission/approval of Class III implantable devices in EU.

Authors and submits IDE and PMA submissions, as well as supplements (5-Day Notice, 30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports etc.). Knowledge of FDA guidance documents and CFR regulations.

Working knowledge of regulatory requirements for Japan, Canada, and other countries is advantageous.

Reviews/approves engineering study protocols/reports and validation study protocols/reports. Reviews and approves manufacturing changes for Class III implantable medical devices.

Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Reports to head of a unit/department.

For this position it will be necessary to bring:

• Bachelor's degree (preferably in medical, science or engineering related discipline) or equivalent combination of education and work experience.

• Preferably 8 years experience in the medical device industry, with 5 of those years related to the preparation of FDA and EU MDR submissions for Class III medical devices.

• Ability to work effectively on project teams. Ability to leverage and/or engage others to accomplish projects

• Must be able to juggle multiple and competing priorities.

• Strong written, verbal, presentation, and organizational skills.

• Working knowledge of QSR, ISO, and EN standards.

• Strong organizational skills and attention to detail.

• Experience reviewing manufacturing operations and changes (change control).

• Solid communication skills and ability to communicate at all levels.

• Ability to think laterally and adapt to change.