Regulatory Affairs Manager (m/f/d)

“We want wow your world!” This is our promise when it comes to work at Freudenberg. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse working environment in which everyone can develop individually. Let yourself be surprised and experience your own “Wow” moments.

Freudenberg Medical is a reliable partner for contract manufacturing organization (CDMO), which delivers high-quality solutions from idea discovery to market launch to series production for medical devices and pharmaceutical companies. Freudenberg Medical has a proven expertise in materials and technologies and offers a comprehensive range of vertically integrated capabilities: precision molds and extrusion, complex catheters, hypotubes and coatings. You support our team as Projektmanager (m/d)

You contribute to the further development of Regulatory Affairs and QM systems according to MDR and ISO 13485 You coordinate international admission and registration procedures for medical devices with proportion of medicinal products You create and maintain technical documentation and communicate with customers, suppliers and authorities worldwide You process government requests and research country-specific approval requirements You support R&D, production and logistics in regulatory compliance and quality issues You maintain change management and accompany design and process changes You prepare audits and conduct them through, including customer and authorities communication

You have a degree in the field of natural sciences, biomedical technology or a comparable qualification You bring experience in medical technology, ideally also in the validation of sterilization processes (ETO) You know the regulatory requirements for medical devices in the EU area (EU-MDR, ISO standards, MPDG); Knowledge in the field of medicine (AMG, GMP) and international (US-FDA) are advantageous You bring a good understanding of medical devices and functional drug coatings with You work independently, structured and team-oriented You are routined in handling MS Office, Adobe Acrobat and QM systems according to EN ISO 13485 You have very good knowledge of German and English in word and writing

Diversity & integration A diversity of experiences, views and people makes us more successful. Health promotion We help you stay healthy and fit and become. Personal development We support you in constantly developing. Occupational pension With the support of the company you can provide for retirement. Employee discount Benefit from discounted offers on products and services. .