Regulatory Manager

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

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.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Roskilde
Rapportér

Lignende jobs

Statistik over udbudte jobs som øvrige i Roskilde

Herunder ser du udviklingen i udbudte øvrige i Roskilde over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.

Se flere statistikker her:
Statistik over udbudte øvrige i Roskilde over tid

Dato Alle jobs som øvrige
19. september 2024 42
18. september 2024 40
17. september 2024 42
16. september 2024 41
15. september 2024 44
14. september 2024 47
13. september 2024 47
12. september 2024 46
11. september 2024 42
10. september 2024 46
9. september 2024 45
8. september 2024 40
7. september 2024 42
6. september 2024 39
5. september 2024 39
4. september 2024 38
3. september 2024 35
2. september 2024 31
1. september 2024 31
31. august 2024 32
30. august 2024 33
29. august 2024 39
28. august 2024 37
27. august 2024 36
26. august 2024 35
25. august 2024 35
24. august 2024 36
23. august 2024 36
22. august 2024 36
21. august 2024 35
20. august 2024 30
Fold ud

Populære søgninger

Lignende søgeresultater

Se alle populære søgninger