Regulatory Specialist - Joensuu

Thermo Fisher Scientific Inc.; Finland; On-site; EUR 45 000 - 65 000; Full time

Job summary

A global leader in scientific solutions is seeking a Regulatory Specialist for their Joensuu factory. The role involves managing compliance information, providing regulatory input, and ensuring documentation accuracy. Candidates should have a relevant Bachelor's degree and at least three years of regulatory experience in medical devices or environmental compliance, with strong communication skills and proficiency in English. Knowledge of Finnish and EU regulations is beneficial.

Qualifications

• Minimum of three years of regulatory work experience in medical devices or environmental compliance.
• Proficient understanding of global regulations for medical device market clearance.
• Skills in Finnish language and understanding of MDR, IVDR, post market surveillance are advantages.

Responsibilities

• Lead management of compliance information for materials and finished goods.
• Provide regulatory input for QA deviations and complaints.
• Assure availability of up-to-date technical documentation for products.

Skills

Regulatory compliance

Communication skills

Critical thinking

Microsoft Office

Education

Bachelor's Degree in regulatory science, chemical/material sciences, biology or engineering

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.

How will you make an impact?

We are looking for a Regulatory Specialist to support our Joensuu factory's operations.

Regulatory Specialist works with our global environmental compliance team to lead all aspects of the management of compliance information for all sourced materials, components and finished goods. This role also gives the opportunity to serve as a Regulatory Assurance SME on new product introductions, capacity expansion projects, and custom product development and manufacturing. You would provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints.

Part of the role's responsibilities is to also assure availability of up-to-date technical documentation and SOP's for Joensuu products and support international registrations with related technical documentation You will also complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products.

How will you get here?

• Minimum of a Bachelor's Degree is required - preferred: regulatory science, chemical/material sciences, biology and engineering
• Minimum of three years of regulatory work experience pertaining to regulations in the medical device or environmental compliance field
• Proficient understanding of the global regulations and standards relevant to medical device market clearance in regions such as US, Canada, and EU
• Strong critical thinking skills with attention to detail as well as ability to maintain visibility of the greater picture
• Effective and collaborative communication style when working with customers, product collaborators, trusted body, and regulatory agencies
• Proficient in Microsoft Office Software (Word, Excel and Powerpoint)
• Excellent communication skills in English (oral and written) is a must.

Skills in Finnish language and understanding of MDR, IVDR, EC Harmonization, post market surveillance activities are considered an advantage.

Application

Apply before the 20.10.2025 via http://jobs.thermofisher.com/. Reference: R-01329740.

The position will be filled as soon as suitable candidate is found. The selected candidate will go through health check which includes a drug test.

About us:

Each one of our 130,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer: http://jobs.thermofisher.com