Group Manager Regulatory Affairs 100%

About the job

We are looking for a Group Manager Regulatory Affairs who will be responsible for our global regulatory strategy, lead a team, ensure compliance with all requirements, and drive efficient processes in a dynamic, international environment.

Group Manager Regulatory Affairs 100%

Your Responsibilities

• Professional and disciplinary leadership as well as further development of a Regulatory Affairs team
• Ensuring compliance with regulatory requirements for the development, manufacture, and market launch of medical devices
• Planning, coordination, and management of regulatory activities and projects
• Professional support and advice to the team and internal stakeholders (R&D, Quality, Production) on regulatory issues
• Responsibility for planning, execution, and monitoring of national and international approval procedures (especially CE marking, FDA)
• Ensuring the quality, consistency, and completeness of technical documentation
• Conducting and monitoring CE conformity assessment procedures
• Leading and reviewing product files (DHF/DHR) as well as conducting design reviews
• Evaluating product changes regarding regulatory requirements and reporting obligations
• Central contact person for authorities, notified bodies, and external partners
• Participation in audits and inspections as well as ensuring successful preparation and execution
• Further development, harmonisation, and implementation of regulatory processes, templates, and tools
• Guidance and support in defining and implementing regulatory strategies

Your Qualifications

• Completed studies in Life Sciences, Engineering, Pharmacy, or comparable field
• Several years of professional experience in Regulatory Affairs in the medical technology or pharmaceutical industry
• Leadership experience and proven experience in the professional management of projects/teams
• Sound knowledge of relevant regulatory requirements
• Experience in technical documentation as well as in approval processes
• Very good German and English skills, both written and spoken
• Confident handling of MS Office and ideally experience with PLM or document management systems
• Strong organisational skills and a high quality awareness
• Strong communication skills and enjoyment in collaborating with various stakeholders
• Structured, solution-oriented, and independent working style

What We Offer

We offer you a responsible and varied role with high quality standards in a growing, international company with progressive social benefits.

About Medartis

At Medartis, we combine innovative solutions with qualified professionals to be the preferred provider in orthopaedics. The Medartis Group was founded in 1997 and is headquartered in Basel, Switzerland. It is one of the world’s leading manufacturers and suppliers of medical technology for the surgical treatment of bone fractures of the upper and lower extremities as well as in the cranio-maxillofacial area. The company employs around 1,400 people at 13 locations and sells its products in over 50 countries worldwide.

For more information, please visit our website www.medartis.com.

We look forward to receiving your complete online application.

We look forward to receiving your complete online application.

Medartis

Human Resources

jobs@medartis.com

www.medartis.com

Human Resources

jobs@medartis.com

www.medartis.com