Regulatory Affairs Expert
23 hours ago
Job Summary
We are seeking a highly skilled Regulatory Affairs Expert to join our team at BioTalent. As a key member of our regulatory team, you will be responsible for driving regulatory strategies and submissions for medical devices.
Key Responsibilities
- Develop and Implement Regulatory Strategies: Collaborate with cross-functional teams to develop and implement global regulatory strategies for clinical applications in various markets.
- Manage Regulatory Submissions: Oversee the preparation and submission of regulatory documents, including 510(k)s, PMAs, and IDEs, to FDA and international bodies.
- Ensure Compliance: Collaborate with clinical and cross-functional teams to ensure compliance with regulatory requirements, including adverse event reporting.
- Lead Technical File Preparation: Lead the preparation of technical files for CE marking and post-market regulatory activities.
Requirements
- Education and Experience: Bachelor's degree in a related field; 5+ years of regulatory experience in the medical device or biotech industry.
- Regulatory Knowledge: Strong knowledge of FDA regulations, EU MDR, ISO 13485, and experience with high-risk devices.
- Communication Skills: Excellent communication skills and ability to work in a fast-paced, dynamic environment.
- Travel Requirements: Ability to travel up to 10% (including international travel).
What We Offer
- Competitive Compensation: Competitive salary ($105K - $130K), stock options, 401k, and health insurance plans.
- Benefits and Perks: Paid time off, flexible schedule, wellness programs, and growth opportunities.
Our Commitment to Diversity
We are committed to diversity and providing equal employment opportunities to all individuals.
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