Regulatory Specialist - Joensuu

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.