Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please
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Overview

Exciting new opportunity for a Regulatory Affairs Professional with good people management skills to join Regulatory Affairs team based in Roskilde, Denmark.

How will you make an impact?

As our new Regulatory Manager, you will be responsible for the overall product safety and regulatory compliance of the manufacturing site located in Roskilde, Denmark, and will work closely with other global sites to ensure product compliance.

You will also be responsible for defining and executing regulatory strategy, providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.

What will you do?

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

• Provide regulatory guidance (e.g. MDR, IVDR, FDA) to the business and project teams. Subject Matter Expert 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

• Contribute 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 stakeholders and existing and prospective external partners. Support Sourcing, Marketing and Commercial Organizations with regulatory requirements interpretation.

• Responsible for signing EC Declaration of Conformities

• Supervising and leading the team

How will you get here?

Education

• B.Sc. degree in Biology, Chemistry, life-science or bioengineering or equivalent

Experience

• Minimum of 4 years Biotechnology/Life Sciences industry experience, with a minimum of 2 years working experience in Regulatory/Quality or an applicable Technical field

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

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

• Experience communicating with Regulatory Authorities and distributors

• Experience with regulatory audits, ISO certification, GMP requirements, risk management and document control

• Experience managing and leading a team

Knowledge, Skills, Abilities

• 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

• High energy level; positive attitude; works well under stress, strong communicator and leader

• Hands-on, action-oriented, and able to implement effectively through his/her 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

• Good people management and stakeholder management skills

• Willingness to travel (~10-20%)

• Comfortable with ambiguity and change

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!

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.