Associate Principal Specialist - Device Manufacturing

Associate Principal Specialist - Device Manufacturing

Ascendis Pharma

Hellerup, Denmark

We are seeking a passionate and result orientated specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in industrialization and globalization of our products. 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 four colleagues, and report directly to Senior Director of Device Manufacturing.

Your key responsibilities will be:

• Prepare devices and drug-device combination products for new markets together with Regulatory Affairs, Device Development specialists, Supply Chain Operations and Quality Assurance.
• Establish plans and coordinate device related activities within globalization and life cycle management. Drive industrialization and improvement projects.
• Collaborate closely with product maintenance managers at our suppliers. Negotiate project offers from suppliers and oversee project cost and progress.
• Act as a specialist for marketed products and share your product knowledge whenever needed.
• Manage changes, deviations, and input to complaints.

Qualifications and Skills:

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

Furthermore, you have:

• Experience within injection devices as well as EU and US regulation of medical devices and drug-device combination products.
• Experience within change control, deviation management and product quality complaints.
• Experience with maintenance of Design History File and Device Master Record. Experience as a Risk Manager is a plus.

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 be a strong communicator and result orientated.
• Travel: 5-10 days per year.

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