Senior Regulatory Affairs Specialist

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 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.

Preferred: Experience with antibody-based diagnostic products. Regulatory Affairs Certification (RAC) preferred. Experience working with electronic Quality Management Systems (eQMS) such as Master Control, AssurX, or Veeva Vault QMS.