Manager Regulatory Affairs (m/w/d)

POLYTECH Health & Aesthetics GmbH; Dieburg, Verwaltungsgemeinschaft Horb am Neckar; Vor Ort; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

An established industry player in medical aesthetics is seeking a Regulatory Affairs Manager to drive international product registrations and ensure compliance with EU and FDA regulations. This role offers a dynamic work environment where you will collaborate closely with various departments, engage with regulatory authorities, and lead training initiatives on regulatory changes. Join a modern, growth-oriented company that values respectful communication and offers flexible working arrangements, comprehensive training, and attractive benefits. Elevate your career in a role that combines strategic impact with operational involvement.

Leistungen

Flexible working hours

Mobile work (home office)

Subsidies for occupational pensions

The givve Card

Access to corporate benefits

Donation for long service anniversaries

Comprehensive training opportunities

Individual training and development opportunities

Qualifikationen

• 5+ years of experience with relevant regulations and standards.
• Qualification as Regulatory Affairs Manager international (TÜV or similar).

Aufgaben

• Initiating and maintaining international product registrations.
• Preparing and evaluating technical documentation and compliance.

Kenntnisse

Regulatory Affairs Management

Knowledge of EN ISO 13485

Knowledge of MDR

Knowledge of 21CFR

Fluent English Communication

Digital Affinity

Ausbildung

Natural Science Degree

Medical Technology Degree

Tools

MS Office

Jobbeschreibung

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 [phone] or by e-mail at Bewerbung[at]polytechhealth.com.