About The RoleWe are seeking an experienced Regulatory Affairs professional to lead medical devices and combination products regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways 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
Develop comprehensive regulatory strategies and technical documentation of medical devices and combination products.Represent the regulatory affairs function in global project teams and governance meetings.Lead regulatory interactions with health authorities and notified 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 current information.Collaborate with CMC and QA departments on device change control processes and global submission requirements.Support internal and external audits related to medical device quality systems.Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.
Skills And Experience
University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related 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, Notified Body opinions, CE certifications).Familiarity with medical devices regulatory framework 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 Veeva and TrackWise would be a plus.
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