Senior Regulatory Affairs Specialist
We are a cutting-edge MedTech company developing technology that uses electrical ablation tech to treat a variety of medical conditions. We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices.
Responsibilities:
- Develop and implement global regulatory strategies for clinical applications in various markets.
- Manage regulatory submissions (e.g., 510(k)s, PMAs, IDEs) for FDA and international bodies (EU MDR, ISO 13485).
- Collaborate with clinical and cross-functional teams to support product registration and compliance.
- Lead the preparation of technical files for CE marking and post-market regulatory activities.
- Serve as the liaison with regulatory authorities and ensure compliance with adverse event reporting.
Requirements:
- Bachelor’s degree in a related field; 5+ years of regulatory experience in the medical device or biotech industry.
- Strong knowledge of FDA regulations, EU MDR, ISO 13485, and experience with high-risk devices.
- Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies.
- Excellent communication skills and ability to work in a fast-paced, dynamic environment.
- Ability to travel up to 10% (including international travel).
Benefits:
- Competitive salary ($105K - $130K), stock options, 401k, and health insurance plans.
- Paid time off, flexible schedule, wellness programs, and growth opportunities.
We are committed to diversity and providing equal employment opportunities to all individuals.
