Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

We are looking for a Regulatory Affairs Specialist to join our team in Vantaa. As a Regulatory Affairs Specialist you will be a crucial part of the Biomarkers, Automation and Instrumentation team, managing regulatory submissions and documentation. Your expertise will help implement successful regulatory strategies.

Key responsibilities

• Develops and implements regulatory strategies for new and modified products.
• Plans, coordinates and prepares document packages for global regulatory submissions.
• Acts as company representative, developing and maintaining positive relationships with authorities through oral and written communications regarding submission pathway development, clarification, and follow-up of submissions under review.
• Acts as a core team member on product development, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• Reviews product and manufacturing changes for compliance with applicable regulations and submits change notifications when applicable.
• Builds and implements departmental policies and procedures.
• Supports primarily software, instrument, and automation product lines, new product development projects, or central initiatives.

• M.Sc. or B.Sc. degree in Software Engineering, Engineering, Biochemistry, or equivalent experience.
• Experience working with quality system requirements (ISO13485, EU IVDR/IVDD, or FDA QSR) and with in vitro diagnostic medical device or related field for two years.
• Understanding about Software as a Medical Device (SaMD) or at least an approach passionate about software.
• Effective interpersonal skills, strong written and verbal communication, and presentation skills.
• Shown time management skills to prioritize multiple ongoing projects simultaneously.
• Strong analytical and problem-solving skills.
• Ability to coordinate and work optimally with cross-functional teams.
• Ability to readily adjust to change in a fast-paced environment and multitask.
• Ability to communicate efficiently with experts in other scientific and technical fields.
• Ability to reach solutions with confidence and integrity.