Mitarbeiter Regulatory Affairs (m/w/d)

Together for innovative medical technology LINK has been researching, developing and producing successfully in the field of endoprosthetics for over 75 years and currently employs approx. 1,200 employees who shape the success of the company through their commitment and qualification. We improve life. Are you there? As a team of dedicated people, we all work together for the patient welfare. In our company we appreciate and promote the diversity of experiences, backgrounds and perspectives of our employees.

In your role as an employee (m/w/d) in Regulatory Affairs, you are instrumental in ensuring that our implants are safe and effective. Your work ensures that all regulatory requirements are met and that our products can be approved worldwide. In this role you work closely with the areas of development, product management, quality management and production. This position is limited to 24 months and serves as a representation during parental leave. You take responsibility for a product portfolio and its regulatory lifecycle You carry out product authorisations at national and international level and support them You are responsible for maintaining existing authorisations You create the necessary documents for the international registration of our products You are a contact person for designated bodies and authorities and carry out change and renewal procedures

Education: You have completed engineering or natural science studies Expertise: You bring first experience in Regulatory Affairs in medical technology, especially in international admissions You have technical understanding You know about non-active medical devices and international admission procedures (FDA, EU, Brazil) You have experience in project management

Soft Skills: You like to work in the team, but also independently You have excellent motivation and work analytical, conscientious and structured You master German and English very well in word and writing

Our job description gives you an insight into the requirements of the position. If you don't bring all the requirements, no problem. For us you count as a human being and your motivation.

Future Industry: You Get a Workplace in Medical Technology Together: Together for the patient good! Onboarding: You start with intensive and structured involvement by experienced team members as well as through our events BE Link and Hey LINK Work-life balance: 37.5 week hours | 30 days holiday | time account | mobile work Future? Secured!: We provide your future, e.g. with an occupational pension scheme incl. Employer subsidy Corporate Benefits: Use numerous employees discounts for numerous cooperation partners Mobility: 25% grant to the Deutschlandticket | free parking | covered bicycle parking | Bikeleasing Remuneration: recommendation bonus for newly recruited employees Movement: Operational sports programs | joint sports events

If you feel addressed by this position and are willing to become part of our dedicated team, we look forward to meeting you.

WALDEMAR LINK GmbH & Co. KG Human resources Sandrine Thiel JOBV1_EN