Senior Regulatory Affairs Specialist

Title: Senior Regulatory Affairs Specialist

Duration: 12-18 months

Location: Pacheco, CA 94553

PR: $50-55.00/hr

Non Negotiable requirements -EU IVDR and or IVDR experience needed

Position Summary

We are seeking an experienced and detail-oriented Senior Regulatory Affairs Specialist to support global regulatory compliance and market access activities for our In Vitro Diagnostics (IVD) product portfolio. This role is responsible for managing international regulatory submissions, maintaining product registrations, supporting product development initiatives, and ensuring continued compliance with global regulatory requirements.

The ideal candidate will have a strong background in IVD regulations, international market registrations, and post-market compliance activities. This position works closely with cross-functional teams including R&D, Quality, Manufacturing, Operations, and Commercial teams to ensure regulatory requirements are integrated throughout the product lifecycle.

Key Responsibilities

Regulatory Strategy & Submissions

• Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets, including the United States, European Union, Canada, Latin America, Asia-Pacific, Middle East, and MDSAP-participating countries.
• Manage product registrations, listings, licenses, renewals, and regulatory approvals to maintain uninterrupted market access.
• Provide regulatory strategy and guidance for new product introductions and lifecycle management activities.
• Coordinate activities with international consultants, distributors, and in-country regulatory representatives.

Product Development Support

• Partner with R&D and Quality teams throughout the product development lifecycle, from concept through commercialization.
• Provide regulatory input regarding design controls, risk management, verification and validation activities, labeling, and change control.
• Assess regulatory impact of product and process changes and support implementation activities.

Regulatory Compliance

• Maintain technical documentation including Technical Files, General Safety and Performance Requirements (GSPR), Clinical Evaluation Reports (CER), risk management files, and supporting regulatory records.
• Ensure compliance with applicable regulations and standards, including IVDR, FDA requirements, ISO 13485, ISO 14971, and MDSAP.
• Monitor changes in global regulations and perform regulatory impact assessments and gap analyses.

Post-Market Surveillance & Vigilance

• Support complaint investigations, adverse event reporting, recalls, advisory notices, and Medical Device Reporting (MDR).
• Lead or support Post-Market Surveillance (PMS) activities, including trend analysis, vigilance reporting, and documentation updates.
• Develop and execute Post-Market Performance Follow-up (PMPF) activities and contribute data to Clinical Evaluation Reports and risk management documentation.
• Support CAPA investigations and implementation of corrective actions.

Quality Systems & Audits

• Collaborate with Quality Systems to ensure compliance with GMP/QSR, ISO 13485, and MDSAP requirements.
• Support internal audits, external audits, inspections, and notified body assessments.
• Prepare documentation and responses to regulatory agency and auditor inquiries.

Training & Continuous Improvement

• Develop regulatory procedures, templates, guidance documents, and training materials.
• Deliver regulatory compliance training to internal stakeholders.
• Participate in continuous improvement initiatives to strengthen regulatory processes and documentation quality.

Required Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Chemistry, Biology, or related field.
• Minimum of 3 years of regulatory affairs experience within the medical device or IVD industry.
• Experience preparing and supporting international regulatory submissions and product registrations.
• Working knowledge of:
  • EU IVDR 2017/746
  • FDA regulations
  • ISO 13485:2016
  • ISO 14971:2019
  • MDSAP requirements
  • Global regulatory frameworks

Preferred Qualifications

• Experience with international submissions in Europe, Latin America, Asia-Pacific, and MDSAP markets.
• Experience with antibody-based diagnostic products.
• Regulatory Affairs Certification (RAC) preferred.
• Experience working with electronic Quality Management Systems (eQMS) such as MasterControl, AssurX, or Veeva Vault QMS.