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Regulatory Affairs Specialist (M/F/D)
Tasks:
Support product lifecycle and new product development projects to ensure ongoing regulatory compliance.
Manage regulatory activities related to product changes, design updates, and lifecycle management.
Review, compile, and maintain technical documentation required for global product registrations.
Prepare and coordinate regulatory submissions, including U.S. premarket notifications (510(k)) and supporting regulatory documentation where applicable.
Support product registration activities across international markets, with a focus on European and U.S. regulatory requirements.
Coordinate regulatory timelines and deliverables in close collaboration with cross-functional teams and external stakeholders.
Participate in product development, engineering change, and quality-related project meetings.
Support regulatory assessments related to design changes, supply chain modifications, CAPAs, and product quality initiatives.
Maintain and update internal regulatory databases and documentation systems.
Ensure regulatory documentation remains accurate, complete, and aligned with applicable global regulations.
Qualification:
Several years of professional experience in Regulatory Affairs within a regulated industry, preferably the medical device sector.
Strong knowledge of European Medical Device Regulations (EU MDR/MDD).
Experience with U.S. FDA regulations and regulatory submission processes, including 510(k) submissions.
Experience preparing and maintaining technical documentation for product registrations.
Good understanding of product lifecycle management and change control processes.
Experience working in cross-functional, international project teams.
Strong organizational, communication, and stakeholder management skills.
Independent, structured, and solution-oriented working style.
Fluent English is required.
Requirements:
Start: 1.9.26
Duration: 7 months
Capacity: Full-time (5 days per week)
Location: remote after onboarding in the greater Hamburg area
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