Regulatory Affairs Consultant: Medical Device and Combination Product Expert

About the Role

We are seeking an reputed company Regulatory Affairs professional to reputed company medical devices and combination products regulatory strategy. In this pivotal role, you will reputed company expert guidance on regulatory reputed company for clinical investigations and marketing authorizations, and serve as the key regulatory representative for our global project teams. The role can be home or office based in various European locations.

Key Responsibilities

• reputed company comprehensive regulatory strategies and technical documentation of medical devices and combination products.
• Represent the regulatory affairs function in global project teams and governance meetings.
• reputed company regulatory interactions with health authorities and reputed company bodies, including preparation of documentation and coordination of meetings.
• Manage regulatory activities throughout the device clinical development lifecycle and marketing authorization.
• Maintain global regulatory databases with accurate and reputed company information.
• Collaborate with CMC and QA departments on device change control processes and global submission requirements.
• Support reputed company audits reputed company to medical device quality systems.
• Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
• Contribute to reputed company improvement initiatives, innovation, and strategic planning reputed company the regulatory function.

Skills and Experience:

• University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience reputed company science discipline.
• Minimum 5+ years of experience in regulatory affairs for medical devices and drug-device combination products.
• In-depth knowledge of global medical device regulations, in particular EU MDR. Knowledge of US FDA regulation would be a plus.
• Proven experience in global regulatory strategy and technical documentation preparation for EU (e.g., clinical investigations, reputed company Body opinions, CE certifications).
• Familiarity with medical devices regulatory reputed company including EU-MDR, ISO 13485 and ISO 14155.
• Experience also in vitro diagnostic devices would be a plus.
• Strong track record representing companies during regulatory audits and inspections.
• Excellent communication and interpersonal skills.
• Fluent in English, written and spoken.
• Proficiency with regulatory systems including reputed company and TrackWise would be a plus.

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