Manager Regulatory Affairs for medical devices
Phillips-Medisize is a leading expert in design, development and production of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide.
We need a new manager for our Regulatory Affairs team. The team is responsible for laying out the regulatory strategy, implementing the approved strategy and for conducting submission/registration, clinical evaluations, and Post Market Surveillance activities for combination products. Some of our product development projects are reaching the launch phase and we are busy to support the global submissions and launches. You will be the manager for eight dedicated and highly skilled employees. You will work close together with two sister teams in the QA/RA organisation and other departments across the organisation as well. The employees from the team are placed both in Struer and Virum and you need to make regular travels to dedicate equal time to your team members. You will report to the Director of Quality Assurance & Regulatory Affairs.
What You Will Do In Your Role
Key responsibilities include:
- Lead and develop a team of highly skilled Regulatory and clinical professionals
- Coaching and development of employees
- Keep overview of the team activities and allocate resources to projects and tasks based on the company priorities.
- Drive team performance to ensure obligations are met
- Be in continuous dialogue with internal and external stakeholders
- Drive alignment within the team, across the organization and optimize processes
- Support decision making to ensure compliance and progress
- Ensure audits and inspections are passed in the development
The Experience You Will Bring
- For this position, the minimum required qualifications are:
- A Master or Bachelors degree in engineering
- Proven experience in leading, motivating and supporting highly skilled staff in professional and personal development
- Solid experience from the medical device industry working within Regulatory Affairs, clinical evaluation and Post Market activities - ideally you have worked with multi discipline medical device development and supplier quality assurance.
You take active lead in complex discussions with hands-on execution. From previous experience you know how to drive regulatory strategies, submissions and updates. At the same time, you are open for input from colleagues and have a team-oriented mentality. You have a holistic mindset and the ability to keep focus on the critical details. In your new role you:
- Understand, handle and utilize the diversity of people
- Understand the value of and exercise value-based management
- Persistent with a systematic approach to your work
- Have drive and can plan, execute and implement changes in an organization
What do we offer
- A challenging position in an international, innovative and successful company in significant growth
- Become part of a team of dedicated, highly qualified and innovative colleagues
- Exciting career possibilities within the constantly growing area of medical devices