Regulatory Affairs Strategist
hace 2 meses
Boston Scientific is a leading medical technology company that prioritizes diversity, equity, and inclusion excellence. Our commitment to innovation and collaboration drives our work forward.
Job Summary:
This role involves working on novel Atrial Fibrillation technology, Pulsed Field Ablation, and ensuring compliance with regulatory agency approvals through change assessments. Responsibilities include reviewing product changes, supporting regulatory submissions, and developing domestic and international strategies for regulatory approval of medical devices. We are seeking a highly skilled individual to join our team as a Regulatory Affairs Strategist.
Key Responsibilities:
- Reviewing product changes to ensure compliance with regulatory requirements.
- SUPPORTING REGULATORY SUBMISSIONS for medical devices.
- Developing domestic and international strategies for regulatory approval of medical devices.
Requirements:
To be successful in this role, you will need:
- A Bachelor's Degree in a relevant field.
- At least 3 years of experience in Regulatory Affairs.
- Working knowledge of US/EU regulatory requirements.
Preferred Qualifications:
We prefer candidates with previous experience with Class II or III medical devices submissions.
Benefits:
Boston Scientific offers a collaborative culture driven by innovation, with opportunities for career growth, life-work integration, and community involvement. We provide a competitive salary and benefits package, including:
- $110,000 per year (estimated).
Join Our Team:
Boston Scientific is committed to fostering a diverse and inclusive workplace where everyone feels valued and empowered to contribute their best work. If you are passionate about regulatory affairs and want to be part of a dynamic team, we encourage you to apply.
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