Senior Regulatory Affairs Specialist - Combination Products

Senior Regulatory Affairs Specialist

Experience: 6–8 Years

Domain: Medical Devices / Combination Products

Role Overview

We 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 Responsibilities

Regulatory Dossier & Technical Documentation

• Prepare, 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 Collaboration

• Partner 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 Support

• Assess 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 Qualifications

• Bachelor’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 2017/745
• FDA 21 CFR
• ICH Guidelines
• ISO 14971 and related standards
• Experience working with:
• Design Dossiers
• Technical Files
• Design History Files (DHF)
• Risk Management Documentation
• Clinical Evaluation Reports (CER)
• Labeling and IFU documentation
• Strong stakeholder management and client communication skills with the ability to work in a collaborative, fast-paced environment.
• Excellent documentation, analytical, and problem-solving capabilities.