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Job summary
A leading medical devices company is looking for a Device Development Lead to guide the design and lifecycle management of medical devices. In this role, you will lead cross-functional teams from concept to regulatory approval and ensure compliance with design control and regulatory standards. Ideal candidates will have 8-10+ years of experience in device development and a degree in engineering or a related field. Strong communication and analytical skills are essential.
Qualifications
8–10+ years leading device or combination product development teams.
Knowledge of ISO 13485, ISO 14971, ISO 62366, GMP.
Knowledge of EU MDR, FDA 21 CFR 820.
Responsibilities
Lead multi-disciplinary device development project teams throughout the full product lifecycle.
Manage project scope, deliverables, schedules, quality, and costs.
Support global regulatory submissions (IND, BLA, NDA, ANDA, MAA, CTD).
Skills
Strong knowledge of design control
Strong communication skills
Analytical skills
Education
Degree or HND in engineering or technical discipline
Job description
A leading medical devices company is looking for a Device Development Lead to guide the design and lifecycle management of medical devices. In this role, you will lead cross-functional teams from concept to regulatory approval and ensure compliance with design control and regulatory standards. Ideal candidates will have 8-10+ years of experience in device development and a degree in engineering or a related field. Strong communication and analytical skills are essential.