Regulatory Affairs Manager

B. Braun Medical AG

Key information

Publication date:16 December 2024
Workload:100%
Contract type:Unlimited employment
Language:German (Fluent), English (Fluent)
Place of work:Sempach

Die B. Braun Medical AG ist eine Tochtergesellschaft der deutschen B. Braun, einer der führenden Hersteller und Lieferanten von Medizintechnikprodukten. Der B. Braun-Konzern beschäftigt über 64'000 Personen in 64 Ländern, davon 1'100 in der Schweiz. Diese sorgen in der Entwicklung, Produktion und dem Vertrieb dafür, dass der Gesundheitsmarkt mit hochwertigen Produkten versorgt wird. Die B. Braun Medical AG ist in der Schweiz an folgenden Standorten vertreten: Sempach, Crissier, Escholzmatt, Luzern und Region Zürich. Mehr unter www.bbraun.ch.

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