Regulatory Affairs Manager
3 weeks ago
At Lifelancer, we are committed to enriching and saving lives through technology and meaningful connections. Our strategy focuses on three main areas: consumer health products that help customers live healthier lives, device-based emergency response services for the active aging population, and virtual care offerings that help to connect patients and physicians.
We are currently seeking a highly skilled Regulatory Affairs Manager to join our team in New York, NY. This is a full-time position that offers a competitive salary of $120,000 per year.
About the RoleThe successful candidate will be responsible for ensuring global regulatory compliance of medical devices throughout their lifecycle, from development to post-market surveillance. Key responsibilities include:
- 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.
- 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.
To be considered for this role, you must have:
- A Bachelor's degree in science, engineering, or a related field.
- Minimum 6 years of experience in medical device regulatory affairs, with a focus on global regulatory strategies and submissions.
We offer a range of benefits, including:
- Comprehensive health insurance.
- Tuition reimbursement and career development opportunities.
- Generous employee discount on Best Buy Health products.
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