Job Post

Senior Regulatory Specialist

Regulatory
Irvine, CA
•
Full Time
Careers
Senior Regulatory Specialist

Responsibilities:

  • Support or lead regulatory submission for US FDA (Q-sub, 510k), EU (CE-Marking), and/or other regulatory jurisdictions.
  • Prepare and maintain technical documentation for FDA 510(k), CE-IVD, and other regulatory jurisdictions.
  • Conduct research to identify and interpret any new/updated regulatory requirements for company products and processes.
  • Perform regulatory assessments for vigilance reporting; support adverse event reporting, field actions, and other post-market surveillance activities.
  • Maintain UDI data in us GUDID and EU EUDAMED.
  • Review and update labeling for compliance to all applicable regulatory requirements.
  • Review promotional materials for regulatory compliance.
  • Support third-party regulatory audits.
  • Collaborate with quality assurance, research & development, product/program management, marketing teams to ensure regulatory requirements are met and collect and coordinate information regulatory documentation for regulatory submissions.

Qualifications: THIS POSITION REQUIRES A MASTER’S DEGREE (OR FOREIGN EQUIVALENT) IN MEDICAL ELECTRONICS, BIOMEDICAL INNOVATION AND DEVELOPMENT, BIOENGINEERING, BIOTECHNOLOGY OR CLOSELY RELATED FIELD, PLUS 3 YEARS OF WORK EXPERIENCE IN THE JOB OFFERED OR CLOSELY RELATED OCCUPATION

Special Requirements:  

EXPERTISE/KNOWLEDGE OF:

  1. Expertise in preparing and managing U.S. FDA submissions (Q-Sub, 510(k), Design Dossiers) and EU CE-Marking under IVDD/IVDR.
  1. Proven experience with international registrations, compiling technical documentation, and meeting distributor/importer requirements.
  1. Skilled in developing regulatory strategies for U.S., EU, and ROW submissions, including assessing needs for clinical testing.
  1. Proficient in ISO 14971 risk management, from development through lifecycle maintenance, ensuring risk identification, evaluation, and mitigation.
  1. Strong background in post-market surveillance, including vigilance reporting, PSURs, and PMPF reports under EU IVDR.
  1. Experience supporting third-party audits, reviewing design control documentation, and ensuring compliance with ISO 13485/14971 and FDA requirements.
  1. Effective collaborator with regulatory authorities, notified bodies, and international partners; adept at regulatory intelligence and risk mitigation

MUST POSSESS EXPERTISE/ KNOWLEDGE SUFFICIENT TO ADEQUATELY PERFORM THE DUTIES OF THE JOB BEING OFFERED. EXPERTISE/ KNOWLEDGE MAY BE GAINED THROUGH EMPLOYMENT EXPERIENCE OR EDUCATION. SUCH EXPERTISE/ KNOWLEDGE CANNOT BE "QUANTIFIED" BY "TIME."

Salary Offered: $97,000 - $139,000 per year

Fluxergy Inc. is an equal opportunity employer.

How to apply: Qualified applicants please send resume to: Alison Barker, people@fluxergy.com. Must reference: BD-26