Regulatory Affairs Strategist for Medical Devices

2 weeks ago


Rancho Cucamonga, California, United States Lifelancer Full time
Job Overview

We are seeking an experienced Regulatory Affairs Specialist to join our team at Lifelancer. This role will be responsible for developing and implementing regulatory strategies to obtain timely approvals from regulatory authorities worldwide.

Key Responsibilities
  • Regulatory Guidance: Provide guidance to cross-functional partners, develop global regulatory strategies for new and modified medical devices.
  • Submission Preparation: Prepare and submit regulatory submission documents for US and OUS regulatory filings under minimal supervision for the EU and supporting outside of US (OUS) geographies.
  • Team Collaboration: Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
Requirements
  • Experience: 4+ years of work experience in regulatory affairs in medical device, biotech, or pharmaceutical industry.
  • Certification: Regulatory Affairs Certification (RAC) preferred.
  • Education: Bachelor's degree in chemistry, scientific or engineering discipline.
Estimated Salary Range

$120,000 - $150,000 per year, depending on experience and qualifications.

Why Join Us?

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. As a member of our team, you will have the opportunity to work with a dynamic and innovative company that values collaboration and expertise.



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