Senior Device Specialist - Device Risk Manager

Ascendis Pharma A/S; Heidelberg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company is seeking a Senior Device Specialist to maintain medical device risk management files, manage changes, and collaborate with various teams for product rollout. The ideal candidate holds a relevant technical degree and has 5-8 years of experience in the medical device or pharmaceutical industry, particularly in risk management, injection devices, and compliance processes. This position is based in Heidelberg, Germany, offering a chance to impact patients' lives through innovative therapies.

Qualifikationen

• 5-8 years of experience within medical device or pharmaceutical industry.
• Formally trained in Medical Device Risk Management (ISO14971:2019).
• Experience with change control, deviation and CAPA management.

Aufgaben

• Maintain medical device risk management files for marketed products.
• Manage changes and deviations.
• Collaborate closely with device leads and QA.

Kenntnisse

Medical Device Risk Management

Injection devices

Analytical skills

Team collaboration

Entrepreneurial mindset

Ausbildung

Relevant technical degree

Jobbeschreibung

Are you passionate about medical devices? Are you experienced within risk management, overseeing external production, and roll out of drug-device combination products?

If so, now is your chance to join Ascendis Pharma as our new Senior Device Specialist.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best‑in‑class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Senior Device Specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in maintaining documentation according to changes of the product, production setup and distribution, as well as market feedback. 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 Manufacturing team consisting of five colleagues, and report directly to Lasse Christoffersen (Senior Director).You will be based in Hellerup, Copenhagen together with the rest of the team.

Your key responsibilities will be:

• Maintain the medical device risk management files for marketed products. Review feedback from patients and information from our production and distribution setup. Review and optimize risk management processes for marketed products. Report to management.
• Manage changes, deviations, and input to complaints.
• Act as a specialist for marketed products and share your product and production knowledge whenever needed.
• Collaborate closely with device leads, QA, Supply Chain, RA, Safety and suppliers to maintain and roll out our products globally.

Qualifications and Skills:

You hold a relevant technical degree and five to eight years of experience within medical device or pharmaceutical industry.

you have:

• Formally trained and proven track record within Medical Device Risk Management (ISO14971:2019). You have reviewed information from production and post‑production activities, initiated relevant CAPA and updated RMF accordingly. Experience with Post Market Surveillance submissions is a plus. (Be specific about your experience in your application.)
• Experienced within injection devices (ISO11608-1&2:2022), design control and drug-device combination product legislation (ISO13485, MDR, 21 CFR Part 820 and 4).
• Experience with change control, deviation and CAPA management, control setup and product quality complaints.
• Experience with maintenance of Device History File, registrations of device and drug-device combination products as well as oversight on supplier services and projects.

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.

Travel: 5-10 days per year.

Office: Denmark, Tuborg Boulevard 12, Hellerup.

Apply now.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company, please contact Lasse Christoffersen, [e-mail]

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.