Job Detail

You’re an important part of our future. Hopefully, we're also a part of yours! At B. Braun, we protect and improve the health of people worldwide. This is also our vision for research and development. You see complexity as an opportunity – and quality and sustainability are important criteria for your work. We would like to work with you on tomorrow’s solutions. That’s how we work to create sustainable healthcare – locally, in regions, countries and worldwide. Together. That's Sharing Expertise.

Swiss Authorized Representative (H/F/D)Reference Code BCR 0601-59219To complete the department of Regulatory Affairs for the Swiss Market in our headquarter in Sempach, we are looking for a Swiss Authorized Representative (H/F/D)

Duties and responsibilities

• Verify that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out.


• Keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56 of MedDO, at the dipsosal of competent authorities for the period of 10 years (15 years for imlantable devices).


• Comply with the registration obligations laid down in Article 31 of MedDO and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29.


• In response to a request from Swismedic, provide all the information and documentation necessary to demonstrate the conformity of a device, in an official language within Switzerland.


• Cooperate with Swissmedic on any preventive or corrective action taken to elminate or, if that is not possible, mitigate the risks posed by devices.

Professional competencies

• Diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent in Switzerland in law, medicine, pharmacy, engineering or another relevant scientific discipline. At least one year of professional Experimenten in regulatory affairs or in quality management systems relating to medical devices is required.


• Alternatively at least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices is required.


• Fluent German, and excellent knowledge of English. French and Italian are a plus.


• Very good knowledge of the Medical Device Regulation. Pharmaceutical Swiss regulation is a plus.


• Experience with Swissmedic is a plus.


• Good knowledge of Word, Excel and Power Point as well as experience with databases.

Personal competencies

• Diplomatic precise, proactive, capacity to work independently and perseverance, your strength guarantees compliance with the regulation.

What we offer

Our promise is Sharing Expertise. The B. Braun company began with a passion for positive change. To this day, we attractpeople who express progressive ideas and implement them together with trust, transparency and appreciation. Becauseall follow the same vision: At B. Braun, we protect and improve the health of people worldwide.

Benefits

• Open and pleasant working atmosphere


• Flat hierarchies and efficient structures


• Interesting working time models


• Various 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

Closing date

01.07.2021