Regulatory Affairs Manager

The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs Manager located at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and surface disinfection as well as medicinal products for use on skin and in wounds.

Diversity is a part of B. Braun Avitum AG. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. We are looking for a passionate and talented individual who will act as an entrepreneur of the global infection prevention portfolio.

Your Tasks & Responsibilities

• Obtain worldwide marketing authorisations and provide regulatory support for medical device registrations
• Creation of technical documentation for obtaining and maintaining global registrations
• Handle variations to the dossier in accordance with the change control process
• Prepare responses to requests by the Competent Authorities and Notified Bodies during the evaluation process, and timely handle deficiency letters within a specific timeframe
• Create and maintain a full up-to-date database and archiving system for tracking the local regulatory dossiers in the region
• Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Production area, Medical Affairs, Marketing)
• Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/Medical Affairs
• Build collaborative relationships with decision-makers and opinion leaders to understand current issues and recognize future trends in the market

Your profile

• University education in the natural sciences (pharmacy, chemistry, biology)
• Further training in the area of regulatory affairs (EU, CH, USA, Asia) would be an advantage
• Experience in the registration of medical devices in the EU and worldwide markets
• Very good written and spoken English and German skills (any additional language skills are beneficial)
• Analytical and structured way of thinking and working
• High organizational and communication skills
• Good teamwork and interpersonal skills

Our offer

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Benefits

• Open and pleasant working atmosphere
• Flat hierarchies and efficient structures
• Flexible working time and home office possibility
• Possible development opportunities
• Active health promotion by supporting external health offers
• Supporting families through our "B. Braun for Family " program
• Various employee benefits e.g., for lunch and more