Senior Regulatory Affairs Specialist

VOLT•Pacheco, CA

7d•Onsite

About The Position

Volt is immediately hiring for a Senior Regulatory Affairs Specialist in Pacheco, California. As a Senior Regulatory Affairs Specialist, you will 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. You will manage product registrations, listings, licenses, renewals, and regulatory approvals to maintain uninterrupted market access. You will also provide regulatory strategy and guidance for new product introductions and lifecycle management activities, and coordinate activities with international consultants, distributors, and in-country regulatory representatives. You will partner with R&D and Quality teams throughout the product development lifecycle, from concept through commercialization, providing regulatory input regarding design controls, risk management, verification and validation activities, labeling, and change control. You will assess the regulatory impact of product and process changes and support implementation activities. You will maintain technical documentation including Technical Files, General Safety and Performance Requirements (GSPR), Clinical Evaluation Reports (CER), risk management files, and supporting regulatory records. You will ensure compliance with applicable regulations and standards, including IVDR, FDA requirements, ISO 13485, ISO 14971, and MDSAP. You will monitor changes in global regulations and perform regulatory impact assessments and gap analyses. You will support complaint investigations, adverse event reporting, recalls, advisory notices, and Medical Device Reporting (MDR). You will lead or support Post-Market Surveillance (PMS) activities, including trend analysis, vigilance reporting, and documentation updates. You will develop and execute Post-Market Performance Follow-up (PMPF) activities and contribute data to Clinical Evaluation Reports and risk management documentation. You will support CAPA investigations and implementation of corrective actions. You will collaborate with Quality Systems to ensure compliance with GMP/QSR, ISO 13485, and MDSAP requirements. You will support internal audits, external audits, inspections, and notified body assessments. You will prepare documentation and responses to regulatory agency and auditor inquiries. You will develop regulatory procedures, templates, guidance documents, and training materials. You will deliver regulatory compliance training to internal stakeholders. You will participate in continuous improvement initiatives to strengthen regulatory processes and documentation quality.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
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.