Regulatory Specialist – Joensuu

Thermo Fisher Scientific Oy; Joensuu; On-site; EUR 45 000 - 70 000; Full time

Job summary

A leading scientific company is seeking a Regulatory Specialist for its Joensuu factory. The role involves managing compliance information for materials and products, supporting international registrations, and performing regulatory safety evaluations. Candidates should have a Bachelor’s degree and at least three years of relevant experience, with strong communication skills in English. Familiarity with Finnish and medical device regulations is advantageous.

Qualifications

• Minimum of three years of regulatory work experience in medical device or environmental compliance.
• Proficient understanding of global regulations relevant to medical devices.
• Excellent communication skills in English (oral and written) required.

Responsibilities

• Support the Joensuu factory's operations through regulatory compliance.
• Lead management of compliance information for sourced materials and finished goods.
• Provide regulatory input to QA in deviations and complaints.

Skills

Regulatory science knowledge

Chemical/material sciences understanding

Strong critical thinking skills

Collaborative communication

Proficient in Microsoft Office

English communication skills

Finnish language skills

Education

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

Job description

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 requirements:

• Minimum of a Bachelor’s Degree – 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.

Osaamisalue: Juridiikka, Teollisuus & tuotanto