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Regulatory Affairs Manager

vor 2 Monaten


Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Position Overview:
At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. We are seeking a dedicated Manager of Regulatory Affairs Clinical to join our dynamic global team. This role presents a diverse and stimulating opportunity within an international setting.

Key Responsibilities:
- Oversee the coordination of external service providers to facilitate clinical evaluation documentation, including Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS).
- Provide support for risk assessments and the planning of studies for CE marking and PMCF initiatives.
- Utilize professional experience in the medical device sector or related regulatory fields.
- Conduct literature searches and reviews, demonstrating expertise in regulatory medical writing.
- Manage databases effectively and possess a strong IT affinity, particularly with the MS Office suite.
- Exhibit fluency in both written and spoken English.

Benefits:
- Flexible international mobile working arrangements.
- Attractive options for balancing work and family life, including childcare subsidies.
- Enjoy 30 days of paid leave annually, along with special leave for significant life events, vacation pay, and additional annual payments as per collective agreements.
- Participate in a company pension plan with appealing employer contributions, alongside various health and wellness initiatives such as skin cancer screenings, online mental health courses, and yoga sessions during lunch breaks.
- Access to Job Bike Leasing.
- Benefit from exclusive discounts on travel, fashion, and technology through our corporate benefits platform.

Join us in making a meaningful impact in the healthcare sector.