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Senior Device Development Specialist

1 week ago

Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

Achieve extraordinary results as a Senior Design Control Specialist in our Device Development team.

At Ascendis Pharma A/S, we are dedicated to making a meaningful difference in patients' lives through the development of new and potentially best-in-class therapies. Our TransCon technology enables us to build a leading, fully integrated biopharmaceutical company that addresses unmet medical needs.

We are seeking a highly skilled Senior Design Control Specialist to join our team and contribute to the development of new drug delivery solutions. This is a unique opportunity to work on complex projects, collaborate with global teams, and drive business growth.

Your key responsibilities will include:

  • Design control of medical devices and combination products for drug delivery
  • Creation of design control documentation, including requirement management and verification, validation, and design transfer documentation
  • Development of packaging and labelling materials
  • Management of design control activities with CMOs and consultants
  • Preparation of regulatory submission documentation

To excel in this role, you should possess a strong academic background in biomedical engineering or a related field, with 5-10 years of experience in the development of drug delivery solutions for drug-device combination products. Experience with medical device design control, packaging and labelling of medical devices, preparation of regulatory submission documentation, and collaboration with CMOs is essential.

This is an excellent opportunity to work in a dynamic environment where innovative ideas and collaboration thrive.