Manager Regulatory Affairs (w/m/d)

Freudenberg; Würselen; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading global technology company in Würselen is seeking an individual for Regulatory Affairs to enhance quality management systems. Responsibilities include coordinating international approval processes and ensuring compliance with medical device regulations. Ideal candidates possess a degree in natural sciences or biomedical engineering and relevant industry experience, along with proficiency in both German and English.

Qualifikationen

• Experience in the medical device industry, ideally validation of sterilization processes.
• Familiarity with EU regulatory requirements for medical devices (EU MDR, ISO standards).
• Good understanding of medical devices and functional pharmaceutical coatings.

Aufgaben

• Contribute to development of Regulatory Affairs and quality management systems.
• Coordinate international approval and registration procedures for medical devices.
• Prepare and maintain technical documentation.

Kenntnisse

Regulatory compliance knowledge

Project coordination

Technical documentation preparation

Team collaboration

Proficient in MS Office

Excellent written and spoken German

Excellent written and spoken English

Ausbildung

Degree in natural sciences or biomedical engineering

Tools

Quality management systems according to EN ISO 13485

Adobe Acrobat

Jobbeschreibung

Working at Freudenberg: We will wow your world!

Responsibilities

• You contribute to the further development of Regulatory Affairs and quality management systems in accordance with MDR and ISO 13485
• You coordinate international approval and registration procedures for medical devices containing medicinal components
• You prepare and maintain technical documentation and communicate with customers, suppliers, and authorities worldwide
• You handle regulatory authority inquiries and research country-specific approval requirements
• You support R&D, production, and logistics in matters of regulatory compliance and quality
• You maintain change management processes and support design and process changes
• You prepare and conduct audits, including communication with customers and authorities

Qualifications

• You hold a degree in natural sciences, biomedical engineering, or a comparable qualification
• You have experience in the medical device industry, ideally also in the validation of sterilization processes (ETO)
• You are familiar with regulatory requirements for medical devices in the EU (EU MDR, ISO standards, MPDG); knowledge of pharmaceutical regulations (AMG, GMP) and international standards (US FDA) is an advantage
• You have a good understanding of medical devices and functional pharmaceutical coatings
• You work independently, in a structured manner, and as part of a team
• You are proficient in MS Office, Adobe Acrobat, and quality management systems according to EN ISO 13485
• You have excellent written and spoken German and English skills

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Hemotech AG