Vacant job

Adecco is now looking for a highly experienced Chief Design Expert for an exciting consulting assignment with a globally leading medical technology company. The role is based in Uppsala and is aimed at you who have a strong background in design control, regulatory requirements, and product development within MedTech.

About the assignment

In the role of Chief Design Expert, you will play a central part in ensuring that products meet regulatory requirements throughout their entire lifecycle. You will work closely with R&D, Quality, and Regulatory Affairs, and be responsible for driving and quality-assuring technical documentation related to design and product changes.

Your responsibilities

• Responsible for maintaining Design Control documentation (DHF, Design Inputs/Outputs, specifications, etc.)
• Drive and ensure correct change control management (change requests, deviations, CAPA)
• Perform and update risk analyses according to ISO 14971
• Support regulatory processes and ensure documentation meets requirements under EU MDR and global authorities (FDA, etc.)
• Contribute to technical projects, such as new product launches, production changes, and verification activities
• Responsible for documentation related to product lifecycle management (LCM)
• Ensure that specifications are scientifically substantiated, traceable, and regulatorily defensible

This is a consulting assignment via Adecco, starting immediately and expected to last until October 31st, with a possibility of extension.

About you

We are looking for a senior specialist with a deep understanding of medical technology regulations and product development.

Qualifications:

• Bachelor's or Master's degree in Biotechnology, Chemical Engineering, or Medical Technology
• At least 8–10 years of experience in MedTech, Pharma, or another highly regulated industry
• Extensive experience in:
  • Design Control
  • EU MDR
  • Risk Management (ISO 14971)
  • Technical Documentation (DHF, risk files, specifications)
• Experience working in QA, RA, or R&D
• Fluent in English, both spoken and written

Preferred qualifications:

• Experience with injectable products or combination products
• Experience with international regulatory submissions (EU/US/CA)

Personal attributes

To succeed in this role, we see that you are:

• Structured and meticulous with a strong focus on quality
• Independent and proactive
• Analytical with the ability to see the big picture
• A skilled collaborator in cross-functional teams

Assignment details

• Consulting assignment via Adecco
• Location: Uppsala
• Start: As soon as possible (according to agreement)
• Duration: Initially approx. 6 months

Contact information

If you have any questions about the position, you are warmly welcome to contact the responsible recruiter:

Amila Dresevic, Adecco – 073 684 78 61

NOTE: We do not accept applications via email.

Selection is ongoing, so don't wait to submit your application!