Head of Regulatory Affairs and Quality Management

Head of Quality & Regulatory Affairs (m/f/d)

 

Location: Tuttlingen, Germany (Hybrid)

 

Overview:

 

Our client has been manufacturing innovative medical devices for over 20 years and has over 150+ employees.

 

Benefits:

1. Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Holiday & Christmas Bonus + Pension Scheme
2. Flexible Work Options: Take advantage of the opportunity work from home 2 days per week + Flexible working hours
3. Generous Vacation Policy: 31-days vacation including 1 day off for your birthday. Recharge and rejuvenate, giving you ample time to relax and enjoy life outside work.
4. Permanent Full-Time Position: Permanent employment in a growing company with secure future prospects.
5. Continuous Evolution & Development: Wide range of development opportunities
6. Responsible and varied tasks working in a fun and diverse team, being responsible for the compliance department
7. Flat hierarchies and short decision-making processes enable you to achieve a lo

 

Tasks:

 

Leadership & Strategy

 

• Head of the Compliance Department with a focus on Regulatory Affairs, Quality Management and Quality Assurance
• Determination of the certification strategy: Medical devices/UL 8139/Drug-Device-Combination, etc.

 

Product Conformity & Approvals

 

• Responsibility for all product approvals and their maintenance in cooperation with internal and external bodies
• Ensuring compliance with standard requirements in close cooperation with R&D
• Assessment and release of technical documentation for medical devices of risk classes I-III under the MDR

 

Risk Management

 

• Responsibility for conducting risk assessments for our medical devices (electrical devices & associated software)
• Intensive cooperation with R&D in defining risk-minimizing measures
• Management of periodic reviews regarding risk assessments

 

 

Your Profile:

 

• Successfully completed degree - ideally with a technical focus (preferably with a doctorate)
• 7+ years of professional and project experience in the specified field of responsibility
• High problem-solving skills and analytical skills to identify and proactively manage complex (partly technical) challenges
• Leadership experience (3+ years)
• A high level of communication skills and enjoyment of working together across interfaces
• Knowledge of quality management and approval of medical devices (ISO 13485, MDR, FDA, etc.)
• Ideally, experience in conducting clinical trials
• You have very good German and fluent English skills, both written and spoken
• Experience working in an international environment

 

 

To apply or for more information, please get in touch with Luke Fines by email at: luke.fines@adaptivelifescience.com