Senior Regulatory Affairs Specialist - Combination Products

Senior Regulatory Affairs SpecialistExperience: 6–8 YearsDomain: Medical Devices / Combination ProductsRole OverviewWe are looking for an experienced Regulatory Affairs Specialist with strong expertise in combination products and medical device regulatory submissions. The role involves supporting client engagements focused on preparation, review, maintenance, and lifecycle management of regulatory dossiers and technical documentation for combination products across global markets.The ideal candidate will work closely with cross-functional client teams including Regulatory Affairs, R&D, Quality, and Clinical functions to ensure submissions are compliant, submission-ready, and aligned with evolving regulatory requirements.Key ResponsibilitiesRegulatory Dossier & Technical DocumentationPrepare, compile, review, and maintain regulatory dossiers and technical files for combination products in accordance with applicable global regulations.Support submission activities for drug-device and biologic-device combination products across markets including EU and US.Maintain and update technical documentation throughout the product lifecycle, ensuring ongoing compliance and audit readiness.Review product labeling, IFUs, clinical documentation, risk management files, and supporting technical data for regulatory adequacy.Client & Cross-Functional CollaborationPartner directly with client stakeholders, including Regulatory, Quality, R&D, Clinical, and Manufacturing teams, to collect and validate submission documentation.Participate in regulatory strategy discussions and provide recommendations to address submission gaps or compliance risks.Coordinate document reviews, approvals, and submission deliverables within defined timelines.Compliance & Regulatory SupportAssess regulatory changes and industry standards impacting combination products and provide guidance on implementation.Support gap assessments, remediation activities, and submission readiness reviews.Ensure documentation aligns with applicable standards including EU MDR, FDA regulations, ISO standards, and ICH guidelines.Track submission milestones, regulatory commitments, and documentation status to support timely execution.Required QualificationsBachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related discipline.6–8 years of hands-on regulatory affairs experience within the medical devices or combination products domain.Proven experience preparing and managing combination product dossiers and technical files for global regulatory submissions.Strong understanding of regulatory frameworks including:EU MDR 2017/745FDA 21 CFRICH GuidelinesISO 14971 and related standardsExperience working with:Design DossiersTechnical FilesDesign History Files (DHF)Risk Management DocumentationClinical Evaluation Reports (CER)Labeling and IFU documentationStrong stakeholder management and client communication skills with the ability to work in a collaborative, fast-paced environment.Excellent documentation, analytical, and problem-solving capabilities.

Apply Now