We're looking for a Regulatory Affairs Specialist I, working in the Pharmaceuticals & Medical Products industry in Cambridge, Massachusetts, United States.
Build and maintain a tracking system for the complete GRA device portfolio.
Liaise with cross-functional portfolio teams to identify programs which require GRA Device support, evaluate stage of program and scope of activities required.
Facilitate resource nomination to support the incoming programs.
Maintain the GRA focal point listing with GRA Device representatives.
Optimize company-specific instructions for medical device submission and health authority interaction templates, building on historical experience from prior submissions.
We're offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Knowledge of relevant medical device regulations (FDA, EU, HC, etc.).
Familiarity with the biopharmaceutical development processes.
Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
Excellent in English language, including technical and regulatory writing skills.
Proficient in MS Word, Excel, PowerPoint
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.