Back to jobs

Regulatory Specialist

Job description

Regulatory Affairs & Quality Control Specialist
Our client is seeking a Regulatory Affairs & Quality Control Specialist to join their team. This role, under the guidance of the Regulatory Affairs Manager and DQO, ensures compliance with the company's Quality Operations and Regulatory Affairs program.
Key Responsibilities:
  • Quality System Compliance: Maintain and assure compliance with ISO 9001, CMDR, FDA (21 CFR 820), FDB, NRC 10 CFR 50 Appendix B, DOT (49 CFR) / IAEA, BIS, MDD (93/42/EEC), ISO 17025, ISO 13485, MDR/MDD, and MDSAP.
  • Regulatory Submissions & Liaising: Author, review, and submit license applications and product registrations. Act as a primary liaison with regulatory agencies and customers for licensing inquiries, product registrations, and import/export compliance.
  • Documentation & System Management: Maintain our client's Quality System documentation (procedures, forms, records). Manage the electronic Document Management System, approve design files/ECOs, and maintain technical files for CE Marking/medical devices.
  • Complaint & CAPA Management: Evaluate and manage customer complaints, maintaining the Customer Contact database. Implement and maintain the CAPA system, including issuance, follow-up, and closure. Conduct root cause analysis for incidents.
  • Auditing: Lead internal audits and function as lead auditor for external supplier audits, including report completion and issuing CAPARs.
Back-up Duties (as needed):
  • Customer Returns: Process customer returns, log into systems, and maintain the returns database.
  • Product Testing: Conduct capsule testing (ISO 2919, DOT Special Form) and Type A package testing (DOT regulations), preparing and communicating test reports.
  • Final & Component QC: Perform final QC on all product lines and orders. Conduct inspection and dimensional QC on components. Process and file NCRs.
Requirements:
  • Education: Bachelor’s degree in a scientific field.
  • Experience: 5+ years in medical devices. Pharmaceutical regulatory experience is a plus.
  • Skills:
    • Proficient in FDA medical device and/or pharmaceutical registrations, regulatory submissions, and agency liaison.
    • Experienced with QA systems: FDA, ISO 13485, MDR/MDD, MDSAP.
    • Self-starter with strong communication, project management, and organizational skills.
    • Detail-oriented with excellent written and verbal skills.
    • Proficient in Microsoft Word, Excel, and ERP/MRP software.
  • Travel: Ability to travel between Valencia and Burbank facilities.