Regulatory Affairs Manager

Job Description :

• This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems.
• pplies 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.
• uthors 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.
• uthors 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.
• 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.
• 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 EUMDR submissions for Class III medical devices.
• bility to work effectively on project teams.
• bility 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.
• bility to think laterally and adapt to change.