Regulatory Affairs Manager

vor 1 Woche

Sempach, Schweiz B. Braun Medical AG Vollzeit

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.

Tasks & Responsibilities

  • Worldwide marketing authorisation and regulatory support for biocides and cosmetics
  • Creation of regulatory documentation for acquiring and maintaining registrations
  • Handle variations to the dossier in accordance with the Change Control process
  • Prepare responses to requests by the Competent Authorities during the evaluation process
  • Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers
  • Effective communication and cross-functional interaction with all involved departments
  • Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests
  • Build collaborative relationships with decision-makers and opinion leaders

Professional skills

  • University education in the natural sciences (pharmacy, chemistry, biology)
  • Further training in the area of regulatory affairs
  • Experience in the registration of biocides and cosmetics
  • Very good written and spoken English and German skills

Personal skills

  • Analytical and structured way of thinking and working
  • High organizational and communication skills
  • Good teamwork and interpersonal skills

What we offer

Our promise is Sharing Expertise. The B. Braun company began with a passion for positive change. To this day, we attract people who express progressive ideas and implement them together with trust, transparency and appreciation.

Because all follow the same vision: At B. Braun, we protect and improve the health of people worldwide.

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