Job Description

　　Job Title: Regulatory Affairs Manager

　　Location: Roskilde, Denmark (hybrid role, office and home-based)

　　At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

　　How will you make an impact?

　　The Sr Regulatory Manager will be responsible for the overall product safety and regulatory compliance of at the manufacturing sites located in Roskilde, Denmark for Laboratory Plastics Essentials (LPE) Business Unit within LPD division. and will work closely with other global sites to ensure product compliance. The individual will be responsible for defining and completing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities. This individual leads a Denmark regulatory team.

　　What will you do?

　　Responsible for regulatory compliance and surveillance. Provides support and informs R&D, Sourcing, Marketing and Commercial organizations about new regulatory compliance trends and developments. Stay ahead of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.

　　Develop regulatory strategy and provide regulatory guidance (e.g. MDR, IVDR, FDA) to the business and project teams. This position serves as a subject matter authority on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.

　　Conduct trainings and/or communicate appropriate materials, like regulatory affairs internal policies and procedures, as needed, in order to enhance team’s knowledge of working in a regulated environment.

　　Compile, review and maintain regulatory submissions, Technical Documentation and labelling for completeness and quality. Prepare and submit tech files and other submissions as needed to regulatory agencies and notified bodies.

　　Chip in within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations.

　　· Perform regulatory assessment of new and changed products. Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.

　　· Review and approve product labelling, packaging advertising, promotional material and other marketing material for compliance with applicable regulations and standards.

　　· Maintain regulated product listing and product classification status as required by governing law and regulatory requirements.

　　· Work with Product Managers to review, evaluate and amend (as appropriate) current product portfolios to assess adequacy of medical device regulatory classification.

　　· Support post-market surveillance and vigilance activities, including submitting reports to authorities.

　　· Participate in internal and external company regulatory/quality audits and assist corporate in carrying out GMP cross-site audits.

　　· Participate in customer audits/technical meetings when applicable.

　　· Participate in business meetings with internals team members and existing and prospective external partners. Support Sourcing, Marketing and Commercial Organizations with regulatory requirements' interpretation.

　　· Responsible for signing EC Declaration of Conformities.

　　· Person responsible for regulatory compliance (PRRC) for IVD and MDR.

　　· May be required to perform other related duties as required and/or assigned.

　　How will you get here?

　　Education

　　· A minimum B.Sc. degree in Biology, Chemistry, life-science or bio-engineering.

　　Experience

　　Minimum of 6 years Biotechnology/Life Sciences industry experience, with a minimum of 3 years working experience in Regulatory/Quality or an applicable Technical field.

　　People management experience is desirable.

　　Experience with biocompatibility testing and extractable and leachable testing is highly desirable.

　　A strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files.

　　Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.

　　Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategy.

　　Direct and positive experience in communicating with Regulatory Authorities and Distributors.

　　Experience in regulatory audits, ISO certification, GMP requirements, risk management and document control.

　　Regulatory review of promotional marketing materials, labeling, etc.

　　Knowledge, Skills, Abilities

　　High energy level; positive attitude; works well under stress, Strong communicator and leader.

　　Hands-on, willing to take action, and able to implement effectively through their team.

　　Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.

　　Able to work autonomously in a matrix-managed organization.

　　Willingness to travel (5-15%)

　　Ready for ambiguity and change

　　Benefits

　　We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

　　As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.