Overview
Bausch + Lomb is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
As a part of the Bausch + Lomb Group the company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses, and other eye surgery products.
Based at our surgical production site in Heidelberg, Germany ( www.storzeye.de ) we are looking for a
Regulatory Affairs Specialist (m/w/d)
Your key responsibilities:
Active support in creating and updating technical documentation for CE Mark in accordance with EU MDR 2017/745
Close cooperation with Regulatory Affairs Manager regarding technical documentation
Support the monitoring and assessing regulation and standard changes to ensure continued compliance
Developing regulatory related SOPs for Quality Management System
Support of regulatory submissions
Supporting QMS audit and inspection
Your profile:
Degree level or equivalent in natural sciences
1-2 years medical device regulatory experience with EU MDD/MDR and US FDA
Knowledge of regulations and standards for medical devices in EU
Excellent written and verbal communication skills
Fluent communication in German and English, both verbal and in writing
Organisational skills
Interpersonal / teamwork skills
We offer:
A permanent employment contract with a competitive remuneration structure (13,5 salaries)
Flexible working time model with the possibility to work from home, 30 days vacation, a secure workplace with an open and personal working atmosphere.
A wide range of further training opportunities and the chance to carry out various training courses and seminars
Health Management
Bike leasing offer, corporate benefits, capital accumulation benefits and more
Teams with outstanding spirit in which we learn from each other and you can develop your potential
To apply for this position, please send your CV and covering letter to
Apply now!