Manager Regulatory Affairs (m/w/d)

POLYTECH Health & Aesthetics GmbH; Dieburg; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

POLYTECH Health & Aesthetics GmbH sucht einen Regulatory Affairs Manager, der internationale Produktregistrierungen initiiert und verwaltet. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um die Einhaltung relevanter Vorschriften sicherzustellen. In einer modernen, wachstumsorientierten Unternehmenskultur erwarten Sie vielgestaltige Aufgaben und umfassende Weiterbildungsmöglichkeiten.

Leistungen

Subventionen für betriebliche Altersvorsorge

Flexibles Arbeiten und Homeoffice

Zugriff auf Firmenangebote

Individuelle Fortbildungsmöglichkeiten

Qualifikationen

• Mindestens 5 Jahre Berufserfahrung mit relevanten Vorschriften.
• Qualifikation als Regulatory Affairs Manager international (TÜV oder ähnlich) erforderlich.
• Detaillierte Kenntnisse von EU- und FDA-Vorschriften.

Aufgaben

• Initiieren und Aufrechterhalten internationaler Produktregistrierungen.
• Vorbereitung und Auswertung technischer Dokumentation.
• Erstellung und Durchführung von Schulungen zu regulatorischen Änderungen.

Kenntnisse

Regulatorische Compliance

Kommunikation

Analytisches Denken

Digital Affinität

Ausbildung

Abschluss in Naturwissenschaften oder Medizintechnik

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 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

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.