You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Regulatory Affairs Manager Company: B. Braun Medical AG
Job Posting Location: CH-Sempach
Functional Area: Regulatory Affairs
Working Model: Hybrid
Requisition ID: 1790
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!
Open and pleasant working atmosphere
Flat hierarchies and efficient structures
Flexible working time and home office possibility
Active health promotion by supporting external health offers
Supporting families through our “B. Braun for Family
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