Our client is seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory activities for new and existing products within its diagnostics, life sciences, and laboratory solutions portfolio. This individual will play a critical role in developing regulatory strategies, preparing regulatory submissions, ensuring ongoing compliance with global regulations, and partnering with cross-functional teams throughout the product lifecycle.
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 agencies and auditor inquiries.
Training & Continuous Improvement
Develop regulatory procedures, templates, guidance documents, and training materials.
Deliver regulatory compliance training to internal stakeholders.
Required:
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:
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.
Numbers & Facts
Location
Santa Clara, CA
Skills
Adverse Eventsunmatched
Antibodiesunmatched
Auditingunmatched
Biologyunmatched
Biomedical Engineeringunmatched
Change Controlunmatched
Chemistryunmatched
Clinical Assessmentunmatched
Clinical Trialunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Distribution Channelunmatched
Documentationunmatched
External Auditunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Gap Analysisunmatched
ISO (International Organization for Standardization)unmatched
Internal Auditunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Product Developmentunmatched
Product Documentationunmatched
Product Lifecycleunmatched
Product Lifecycle Managementunmatched
Product Managementunmatched
Product Supportunmatched
Product/Service Launchunmatched
Quality Managementunmatched
Quality System Requirements (QSR)unmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Submissionsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Safety Trainingunmatched
Strategic Planningunmatched
Surveillanceunmatched
Technical Writingunmatched
Trend Analysisunmatched
Validation Testingunmatched
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