Senior Design Control Specialist

Senior Design Control Specialist

Ascendis Pharma

Copenhagen, Denmark

We are seeking a passionate Senior Design Control Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in the development of new drug delivery solutions. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Device Development team, and report directly to the Head of Device Developmentwho is based in Hellerup. You will also be based in Hellerup.

Your key responsibilities will be:

• Development and design control of medical devices and combination products for drug delivery
• Preparation, review and maintenance of design control documentation including requirement management as well as verification, validation and design transfer documentation
• Development of packaging and labelling materials
• Coordination of design control activities with CMOs and consultants
• Preparation of regulatory submission documentation

Qualifications and Skills:

You hold a relevant academic degree – preferably a M.Sc. or Ph.D. of mechanical, biomedical or pharmaceutical engineering – and 5-10 years of experience within development of drug delivery solutions for drug-device combination products.

Furthermore, you have:

• Experience with medical device design control (according to relevant regulations and guidelines)
• Experience with packaging and labelling of medical devices
• Experience with preparation of regulatory submission documentation
• Experience with CMO collaboration

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you to have good communication skills and the ability to handle multiple tasks and opportunities simultaneously.

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