Regulatory Affairs Specialist

4 weeks ago


Pleasanton, California, United States EPM Scientific Full time
Job Title: Principal Regulatory Affairs Specialist

We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulatory requirements.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with global regulatory requirements
  • Prepare and submit regulatory applications to FDA and international agencies
  • Coordinate and compile regulatory submissions, including EU dossiers, Premarket notifications, PMA supplements, and change notifications
  • Maintain annual licenses, registrations, and listing information
  • Act as the subject matter expert (SME) for audits and inspections with internal and external authorities
  • Review and edit promotional materials

Requirements:

  • Minimum 5+ years of experience with Class II and/or Class III medical devices
  • Experience authoring and submitting 510k applications and PMA supplements
  • RAC Certification

Preferred Qualifications:

  • 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)
  • Strong technical writing skills
  • Ability to travel 5%, including international travel

About EPM Scientific:

EPM Scientific is a leading pharmaceutical company with a strong commitment to innovation and quality. We are seeking talented individuals who share our passion for delivering exceptional results and making a meaningful impact in the industry.



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