Your strength

Successfully completed studies in natural sciences or engineering, or a comparable qualification.
At least four years of professional experience, ideally in the field of Regulatory Affairs in medical technology.
Experience with Class IIa/IIb or III medical devices and with international approvals.
Good knowledge of global regulatory requirements, product development, and regulatory processes throughout the entire product lifecycle.
Ability to understand and evaluate complex technical, physiological and regulatory relationships.
Strong analytical skills as well as very good written and oral communication skills.
A structured, independent work style and the ability to flexibly manage priorities and independently drive regulatory projects forward.
Proficient use of common MS Office applications.
Excellent German and English skills, both spoken and written.

Your contribution

Independent handling and support of global regulatory activities for new medical devices as well as for maintaining existing product approvals.
Regulatory assessment of product changes and coordination of the necessary activities with international regulatory affairs teams and internal departments.
Handling complex regulatory issues and providing support in answering inquiries from international regulatory authorities.
Close collaboration with interdisciplinary teams and subject matter experts to ensure regulatory compliance in development projects and in the maintenance of technical documentation.
Support for regulatory commercialization activities, including labeling, evaluation of marketing materials, and product registrations and approvals.
Creation and updating of regulatory data sheets for international registration procedures.
Regulatory support for clinical trials, including the submission of required documents and handling of regulatory inquiries.
Participation in quality-relevant processes such as change management, CAPA, NCR, PMS, risk management, and internal and external audits.
Ensuring complete, up-to-date and audit-compliant regulatory documentation as well as adherence to internal quality processes.

Participation and responsibility in an independent area of responsibility
Intensive onboarding with a buddy program
An internationally successful medical technology company with a modern campus and high-quality equipment.
An open, friendly team that looks forward to your support
Attractive benefits such as bicycle leasing, incentive car leasing, the EGYM Wellpass corporate fitness program, and other corporate benefits.
In-house canteen with subsidized meals

Responsibilities