RA Device Director
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Master's Degree
Total Vacancies
1 Job
Posted on
Jun 3, 2021
Last Date
Jul 3, 2021
Location(s)

Job Description

Associate Director/Director RA Device

Join theGlobal Regulatory team in a leading and fast-growing biotech company

Ascendis Pharma is currently expanding its regulatory team and need more expertise with RA device and combination products

You will be responsible for regulatory medical device activities and ensuring that medical devices are compliant with the US and the EU Medical Device Regulation. You will be part of the cross functional medical device teams across several projects.

As RA Device responsible, you will join our growing global Regulatory Affairs team currently consisting of 25 colleagues in DK and US, and you will report directly to the Senior Director, Regulatory Strategy.

Main areas of responsibility:

  • Ensure compliance with US and EU regulations and support our collaborators in other regions
  • Provide strategic and operational support on device regulatory aspects in Ramp;D projects
  • Oversee 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
  • Be an integral part of the Ascendis Device Team and Liaise with regulatory counterparts at our CMOs

Criteria of success in the role will be to build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.

You hold a university degree within Natural Science or a related field.

You have at least -10 years of documented professional experience from a Regulatory Affairs device position preferably in the Pharma industry. You are able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You are passionate about creating a sustainable footprint rather than building a career. However, Ascendis Pharma is growing rapidly, as will Regulatory Affairs, and there will be opportunities as the organization develops.

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 our exciting product pipeline.

Travelling: 10-15 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.

For more details about the job or the company, please Eva Gamwell Henriksen + 45 26432166 or . All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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