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Director, Regulatory Affairs (Device)

In a fast growing Biotech Company

Ascendis Pharma is in the process of expanding its pipeline with more drug candidates and is putting considerable emphasis on the further clinical development of its own products. A late stage project is also moving towards marketing registration and commercialization, and they are now looking for a Director, Regulatory Affairs with focus on devices.

As Director, Regulatory Affairs (Device) at Ascendis Pharma you will be a key member of the Regulatory Affairs team and provide effective support to the organization to ensure the best development programs for your designated projects. You will be responsible for strategic and operational regulatory oversight for devices worldwide, including drug/biologic/device combination products, in collaboration with the rest of the RA and technical teams. It is a once in a lifetime opportunity to be part of setting up the structure and function of Regulatory Affairs regarding device related activities. The position does not contain managerial responsibility.

With direct report to Senior Director, Regulatory Affairs.

Your main tasks are:

  • Provide strategic regulatory guidance and input for the preparation and submission of device documentation to support investigational and marketing registration packages throughout the world and ensure timelines are met, including writing and review of relevant device sections of IND/CTA, NDA/BLA/MAA, and other global submission documents
  • Ensure the product Medical Device Files are in compliance with the US regulation and the new EU Medical Device Regulation
  • Provide stragetic and operational support on device regulatory aspects in R&D projects
  • Provide Regualtory Affairs support with regard to device design changes, assesments and regulatory impact and Postmarketing Safety Reporting (collaboration subcontractors for combination products)
  • Handle Regulatory Affairs device and drug/biologic/device combination products tasks, including involvement in device and facility registrations, and participation in Risk Management Files including the development of the Device Master Files
  • Support the interaction with global regulatory authorities as needed for device related aspects review and approvals
  • Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met
  • Contribute to internal regulatory policies and procedures to achieve best practices and work processes by writing SOPs
  • Support the company through regulatory intelligence efforts by staying abreast of newly issued regulatory laws, guidance and technical publications as appliced to devices 

Your qualifications include a proven record of accomplishment and at least 8-10 years of documented professional experience from a Regulatory Affairs device position from a pharmaceutical/biotechnology company preferably working with injection devices/combination products. Further, you have experience with regulatory device lifecycle management and interactions with Health Authorities and knowledge of international legislation and standards. 

You have a Master’s Degree within Natural Science or a related field but most important, extensive regulatory device experience working with regulations of medical devices. In addition, you have excellent verbal and written skills and are able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.

You are a person who thrives on being challenged and working in collaborative environments.  Strong interpersonal skills are necessary, as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, an ability to think and manage strategically with attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance their exciting product pipeline and get the first product on the market.

Travelling: 15-20 days per year.

Domicile: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.

For more details about the job or the company, please contact Research Consultant, Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
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