What are the responsibilities and job description for the The Ranger Group | Regulatory Affairs Specialist position at The Ranger Group?
Ranger has a Contract to Hire opportunity for a Regulatory Specialist with one our large Medical Device customers in the Bay Area. The role would start on a Contract basis with the goal of converting to full-time in the future. This person will lead project submissions for regulatory approvals and act independently to identify and resolve problems. They will apply advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.
Description
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.
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.
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.).
Requirements
- A minimum of 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.
- Experience with class III implantable devices
- Knowledge of FDA guidance documents and CFR regulations.
- Knowledge of EU MDR requirements and other applicable EU regulations
- Working knowledge of QSR, ISO, and EN standards.
- Experience reviewing manufacturing operations and changes (change control).
- Bachelor's degree (preferably in medical, science or engineering related discipline) or equivalent combination of education and work experience.
- This role is fully onsite
