Regulatory Manager
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Roskilde
Job Title: Regulatory Affairs Manager
Location/Division Specific Information
Denmark – Roskilde
How will you make an impact?
The Regulatory Manager will be responsible for the overall product safety and regulatory compliance of at the manufacturing sites located in Denmark, Roskilde, will work closely with other global sites to ensure product compliance. The individual will 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. This position serves as a 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 team members
- May be required to perform other related duties as required and/or assigned.
How will you get here?
- A minimum B.Sc. degree in Biology, Chemistry, life-science or bio-engineering.
- 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.
- 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.
- People management/supervising a team
Knowledge, Skills, Abilities
- 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
- Willingness to travel (~10-20%)
- Comfortable with ambiguity and change
- People management
Please send in your application, including a cover letter and CV. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.
If you have questions about Thermo Fisher Scientific and/or the position - please contact Nina Albuquerque, Sr Recruiter: [email protected]
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
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Roskilde.
Jobbet er oprettet på vores service den 30.5.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Roskilde
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