Global Regulatory Compliance Expert
7 days ago
At Best Buy Health, we're committed to enriching and saving lives through technology and meaningful connections.
We're seeking a seasoned Regulatory Affairs Manager to join our team in Boston, MA. This is a full-time position that offers a competitive salary of $120,000 per year.
Job Description:
- Develop and implement comprehensive global regulatory strategies for new and existing medical devices, ensuring compliance with US (FDA), EU (MDR), and international regulations.
- Lead the preparation and submission of regulatory filings for US (510(k), PMA), EU (CE Marking), and other international markets (as applicable).
- Manage the regulatory approval process, interacting with regulatory agencies and ensuring timely responses to inquiries and requests.
- Identify and manage regulatory risks associated with product development and commercialization.
- Lead the development and implementation of post-market surveillance plans (PMS) in accordance with regulatory requirements.
Required Skills and Qualifications:
- Bachelor's degree in science, engineering, or a related field required
- Minimum 6 years of experience in medical device regulatory affairs, with a focus on global regulatory strategies and submissions required
Benefits:
- We offer a comprehensive benefits package, including tuition reimbursement, caregiver support, and more.
- You'll also enjoy a generous employee discount at Best Buy stores.
About Us:
Best Buy Health aims to make a meaningful impact on people's lives through innovative healthcare solutions. We value diversity and inclusion, and we're an equal opportunity employer.
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