Regulatory Affairs & Quality Consultant
Contract Length: 12 Months
Start Date: Mid-October 2026
Engagement: Freelance
This assignment is ideal for an independent consultant with strong experience across medical devices, combination products, drug delivery systems, and quality management systems.
Key Responsibilities
- Lead regulatory strategy and execution for drug delivery and medical device projects across global markets.
- Drive regulatory submissions, registrations, and lifecycle management activities in the EU and other key regions.
- Support the development, enhancement, and ongoing effectiveness of the Quality Management System in line with ISO 13485.
- Prepare and review technical documentation, regulatory dossiers, and design control documentation.
- Act as the primary point of contact for regulatory agencies, Notified Bodies, and external auditors.
- Provide regulatory guidance throughout product development, verification, validation, and design transfer activities.
- Support risk management, change control, and compliance activities across product portfolios.
- Partner with Engineering, R&D, Quality, and Operations teams to deliver key regulatory and business objectives.
Key Requirements
- Proven Regulatory Affairs experience within medical devices, combination products, or drug delivery systems.
- Strong knowledge of EU MDR, ISO 13485, and product development lifecycle requirements.
- Experience preparing technical files, regulatory submissions, and supporting product registrations.
- Previous interaction with Notified Bodies, regulatory authorities, and external audit teams.
- Ability to operate independently and drive complex regulatory projects within a fast-paced environment.
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