Regulatory Affairs Manager

3 weeks ago


New York, New York, United States Lifelancer Full time

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 Role

The 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.
Requirements

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.
What We Offer

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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