Regulatory Affairs Specialist

4 days ago


Atlanta, Georgia, United States EPM Scientific Full time

Job Title: Principal Regulatory Affairs Specialist

About the Role:

EPM Scientific is seeking a highly skilled Principal Regulatory Affairs Specialist to support the growth of our medical device and diagnostics portfolio. As a key member of our regulatory team, you will play a critical role in ensuring compliance with FDA and international regulations.

Key Responsibilities:

  • Act as the regulatory representative on core product development teams, providing input on FDA and international product registrations and licensing requirements.
  • Develop global strategies for new and modified products, ensuring compliance with regulatory requirements.
  • Prepare and submit PMA and IDE submissions and supplements, as well as international product registrations and licensing applications.
  • Maintain licensing, registration, and listing information, ensuring accuracy and compliance.
  • Support the product release process by creating GTS licenses, ensuring timely and compliant product launches.
  • Review and advise on labeling, product claims, and ad promo brochures, ensuring regulatory compliance.

Requirements:

  • Minimum 5+ years of experience in Regulatory Affairs, with at least 3 years working directly on class III medical devices.
  • Must have 510k and PMA submission experience.
  • RAC Certification.
  • Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
  • Experience with medical device software requirements and software regulations.

What We Offer:

EPM Scientific offers a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply.



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