Manager Regulatory Affairs (m/w/d)

Your mission

• 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

Your profile

• 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

Why us?

• 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 and 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

Contact details

Elevate your career with a role that offers both strategic impact and operational involvement at a global leader in medical aesthetics. Our HR department will be happy to answer your questions from Monday to Friday between 8:00 am and 5:00 pm on +49 6071 9863 1718 or by e-mail at Bewerbung[at]polytechhealth.com.