QA/RA Consultant – Medical Devices

Do you want to be part of work that genuinely matters, helping innovative medical devices reach patients safely and compliantly?
At MDS Finland, we’re passionate about medical technology and proud to support our customers in bringing new innovations to market. Now we’re looking for a QA/RA Consultant to strengthen our growing team.

What you’ll do

As part of our QA/RA consulting team, you’ll work with a wide range of medical device customers and projects. Your tasks may include:

• Building and developing Quality Management Systems according to ISO 13485, MDR (EU 2017/745), IVDR (EU 2017/746) and FDA requirements
• Creating and maintaining Technical Documentation / Technical Files in line with MDR/IVDR and harmonized standards
• Preparing clinical documentation such as CEP/CER and supporting clinical evaluation work
• Compiling FDA 510(k) submissions and supporting other global registrations
• Developing regulatory strategies for different markets and device types
• Clarifying regulatory requirements, standards, and routes to compliance
• Participating in project planning and management together with customers and internal teams

You won’t be doing the same thing every day, our assignments are varied, hands-on, and often solve complex QA/RA questions.

What we’re looking for

You might be the person we’re looking for if you recognize yourself in most of these:

• 3+ years of experience in the medical device industry (QA, RA or both)
• Practical experience creating technical documentation and/or clinical evaluation documentation
• Experience building or improving QMS and guiding others toward compliance
• A true interest in medical devices, new innovations, and market access
• A solution-oriented mindset, you look for opportunities, not roadblocks
• Ability to work independently, take ownership, and also collaborate closely with others
• Motivation to develop your expertise and share knowledge with colleagues

Education & languages
We hope you have an academic degree in a relevant field, and strong written and spoken Finnish and English. Other language skills are a plus.

What we offer

• Meaningful work with innovative medical device companies
• A supportive, professional consulting team where learning is part of the job
• Free coffee/tea and free gym access at our current location
• A small, low-hierarchy work community where everyone’s input matters
• Salary range 3,800–4,500 € / month, depending on your experience

Interested?

Send us your application and CV, and tell us briefly why this role excites you.
Let’s build safer, smarter medical devices together.