Our company is involved in the supply of high-quality products and services intended for diagnostic laboratories. Independence, innovation and commitment are the fundamental values that permeate our company culture, as well as a strong orientation towards our customers and a multicultural environment. With an international scope, Bio-Rad is now looking for a Regulatory Affairs Specialist (m/f/d) - 100%.
How You’ll Make an Impact
- You ensure the compliance of our IVD medical device portfolio with the requirements of the European IVD Directive 98/79/EC and Regulation 2017/746 throughout the product life cycle (development, manufacture, placing on the market)
- You build up the technical documentation of our reagents, instruments and software, and update it in light of changing regulatory requirements
- You are responsible for coordinating submission of registration files to the Notified Body, and registration dossiers for the worldwide registration of our products in a timely manner
- You work closely with representatives of our subsidiaries (North and Latin American, Asia Pacific, Eastern Europe, Middle East, and Russia) to define the regulatory strategy and meet local requirements as well as with representative from project teams to ensure adequate solutions are implemented to ensure successful registration.
What You Bring
- You benefit from a scientific university degree in biology or pharmacy (Bachelor or equivalent level) with ideal knowledge of immuno-hematology
- You stand out by your writing skills and can clearly present complex situations (both written and oral)
- You have good skills to analyze and synthesize technical data
- You have min. 3 years of experience in regulatory affairs and have a good knowledge of life cycle management on medical devices and/or in vitro diagnostics.
- FDA regulatory knowledge is an asset (e.g. 510k, PMA, BLA)
- You have a very good command of spoken and written English. Good command of German and/or French would be a strong asset.
What we offer
- Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall wealth and wellbeing of our employees through the various stages of an employee’s work and life cycle. We’re proud to offer a variety of options, including:
- Competitive salary
- Company restaurant
- Annual bonus & salary review
- Hybrid working model (3 days on site and 2 days home office)
- Marriage and childbirth allowance
- Employee Referral scheme
- Contribution to fitness subscription
- Employee assistance programme
- Training & Development programs, with access to LinkedIn Learning
If you feel attracted to this opportunity and you would like to take on new challenges, please submit your complete application (application letter, CV, copies of work certificates and diplomas/degrees, etc.), we would like to get to know you.
