Jobbeschreibung
POLYTECH Health & Aesthetics GmbH is one of the world's leading suppliers of medical products in the field of aesthetic and reconstructive surgery. We produce exclusively at our company site in Dieburg (Hesse) and from there, in addition to the German market, we supply sales partners in more than 80 countries around the world. As an innovative company, we are always on the lookout for talented and motivated employees who want to shape the future together with us.
- Initiating and maintaining international product registrations
- Preparation, maintenance and evaluation of technical documentation, including monitoring and gap analysis of (inter-) national regulations and standards
- Examination and monitoring of instructions for use and labelling in accordance with the relevant directives
- close cooperation with and communication to departments (R&D, QA, Production), customers and authorities involved
- Creating and delivering training on regulatory changes and requirements
- completed studies, ideally with a natural science background or in medical technology
- Professional experience (min. 5 years) in dealing with relevant regulations and standards (EN ISO 13485, MDR, 21CFR)
- Qualification as Regulatory Affairs Manager international (TÜV or similar)
- Detailed knowledge of EU and FDA regulations and experience with submissions for class III devices
- Qualification as auditor desirable
- high digital affinity, excellent knowledge of MS Office
- fluent English skills, necessary for effective communication
- a varied and challenging activity in a modern, growth-oriented company in a leading market position
- a respectful and solution-oriented communication with extremely flat hierarchies with short decision-making paths
- a safe and attractive workplace
- Subsidies for occupational pensions
- the givve Card®, a voucher card that is charged monthly
- Access to corporate benefits, a benefit portal with attractive discounts
- Donation for birthday and company anniversary at 5, 10, 15 and 20 years of service
- flexible working hours and mobile work (home office)
- comprehensive and systematic training
- individual training and development opportunities