Manager Regulatory Affairs (w/m/d)

Freudenberg Group; Deutschland; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A global leader in medical devices is seeking a Regulatory Affairs Specialist to enhance quality management systems and coordinate approval processes for medical devices. The role involves preparing technical documentation, managing inquiries from regulatory authorities, and supporting R&D, production, and logistics. A degree in natural sciences or biomedical engineering and proficiency in both German and English are essential.

Qualifikationen

• Degree in natural sciences, biomedical engineering, or comparable qualification.
• Experience in the medical device industry, ideally in validation of sterilization processes.
• Familiarity with regulatory requirements for medical devices in the EU.

Aufgaben

• Develop regulatory affairs and quality management systems.
• Coordinate international approval for medical devices.
• Prepare and maintain technical documentation.

Kenntnisse

Experience in the medical device industry

Knowledge of EU regulatory requirements

Excellent written and spoken German skills

Excellent written and spoken English skills

Proficiency in MS Office and Adobe Acrobat

Understanding of quality management systems

Ausbildung

Degree in natural sciences or biomedical engineering

Tools

Quality management systems (EN ISO 13485)

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.

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