08151 5551666 info@bandao.de

Regulatory Affairs
Bayern, München, PLZ 8
Posted 2 Wochen ago

BANDAO recruits for Bausch + Lomb. Bausch + Lomb, a division of Bausch Health, is one of the best-known and most respected health care brands worldwide. Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology.

Approximately 21,000 employees are united around Bausch + Lomb’s mission of improving people’s lives with health care products. Bausch + Lomb manufactures and markets health care products directly or indirectly in approximately 100 countries.

BANDAO recruits for the LASIK division – Technolas Perfect Vision – in Munich a:

Senior Specialist, Regulatory Affairs (m/f/d) – LASIK

– Support of EU as well as international product registrations
– Contact person for Distributors, Notified Bodies and Competent Authorities regarding product approvals
– Maintain “Technical File” of company products (mostly LASIK but also PEMS and sterile products) according to MDD 93/42 EEC
– Support maintenance of Regulatory Affairs data base
– Regulatory support for TPV’s PEMS devices
– Risk management according to ISO 14971

– Bachelor or equivalent degree with a scientific or engineering background (FH/Univ.)

At least 5-year experience in regulatory affairs of medical devices; Experience in minimum one of the following fields is required:
– According to DIN EN 62366
– Risk management according to EN ISO 14971:2012

– Fluent English and German
– Good communication skills

If you are interested and qualified, please send us your resume as a Doc, RTF or PDF-File in English. Motivation letter is not required but salary expectation and notice period.

Bausch + Lomb is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Job Features

Job CategoryMedizintechnik
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