We are currently looking for top talents who wish to introduce their knowledge, ideas, and aspirations into our highly dynamic, fast-growing, international team.
Our core business is the development and manufacture of innovative, customised solutions for the problems faced by patients and healthcare professionals around the world in the highly innovative Orthopaedic market. With this in mind we are currently searching for a Head of Regulatory Affairs & Quality Management to lead the team in Germany.
Key Responsibilities of the Head of Regulatory Affairs & Quality Management:
• Responsible for timely approval for new product submission, change notification, license renewal to International regulatory authorities and addressing questions and observations related during the process
• Accountable for people management of the direct report(s), including accurate budgeting, objective setting, performance review, coaching and development
• Development of International regulatory strategies in alignment with global strategy for new and existing products
• Effective relationship management with Governing Bodies, Third Party agencies, Consultants, and internal stakeholders in order to meet the Quality and Regulatory targets
• Keeping Oversight of the changing Quality and Regulatory environment Internationally the risks and execute the plan to overcome the risks
• Overall responsibility of the the Quality Management System (QMS)
The profile of the Head of Regulatory Affairs & Quality Management:
• University Degree in Science (Pharmacy, Medical Technology) or related degree/diploma in Science, Engineering, and/or Biotechnology. Degree in Engineering or equivalent technical experience
• Minimum 5 year working across either Quality or Regulatory Affairs in Medical Device/Pharmaceutical industry
• Experience with management of preferably class III medical device submissions Internationally
• Good German and English level in both writing and speaking.
• Great interpersonal and communication skills
If you believe this role could be of interest, or you would like to find out more, please apply or get in touch today.