Regulatory Manager
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Roskilde
Regulatory Manager
Exciting position within regulatory affairs and people management
https://uhc.dk/wp-content/uploads/2020/09/Videoannonce_ThermoFisher.mp4
As the new Regulatory Manager at Thermo Fisher, you will be responsible for the overall product safety and regulatory compliance of the manufacturing site located in Roskilde, and you 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. You will have two specialists in direct report.
Key responsibilities include:
Your qualifications are a 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. Moreover, you have experience as RA representative on project core teams providing active and successful regulatory guidance and RA strategy. You have experience communicating with Regulatory Authorities and distributors together with experience with regulatory audits, ISO certification, GMP requirements, risk management and document control. Moreover, you have experience managing and leading a team.
You have a strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files. Finally, you must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
You have a Bachelor Degree in Biology, Chemistry, Life Science, Bioengineering or equivalent.
You are a person with a high energy level, a positive attitude and you work well under pressure, together with being a strong communicator and leader. You are hands-on, action-oriented, and able to implement effectively through your team. You are continuously improvement minded, familiar with balancing the need for Quality and the need for efficiency and you are able to work autonomously in a matrix-managed organization. You have good people management and stakeholder management skills and you are comfortable with ambiguity and change.
Thermo Fisher offers an exciting position in which you will have a high degree of influence on your own job. The position will allow the you to create a sustainable footprint while developing professionally.
Travelling: 10-20% per year.
Domicile: The Thermo Fisher domicile in Roskilde.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.
Exciting position within regulatory affairs and people management
https://uhc.dk/wp-content/uploads/2020/09/Videoannonce_ThermoFisher.mp4
As the new Regulatory Manager at Thermo Fisher, you will be responsible for the overall product safety and regulatory compliance of the manufacturing site located in Roskilde, and you 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. You will have two specialists in direct report.
Key responsibilities include:
- Responsible for regulatory surveillance. Provide support and inform 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 coordinate 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 the 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 requirement
- 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 internal 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
Your qualifications are a 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. Moreover, you have experience as RA representative on project core teams providing active and successful regulatory guidance and RA strategy. You have experience communicating with Regulatory Authorities and distributors together with experience with regulatory audits, ISO certification, GMP requirements, risk management and document control. Moreover, you have experience managing and leading a team.
You have a strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files. Finally, you must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
You have a Bachelor Degree in Biology, Chemistry, Life Science, Bioengineering or equivalent.
You are a person with a high energy level, a positive attitude and you work well under pressure, together with being a strong communicator and leader. You are hands-on, action-oriented, and able to implement effectively through your team. You are continuously improvement minded, familiar with balancing the need for Quality and the need for efficiency and you are able to work autonomously in a matrix-managed organization. You have good people management and stakeholder management skills and you are comfortable with ambiguity and change.
Thermo Fisher offers an exciting position in which you will have a high degree of influence on your own job. The position will allow the you to create a sustainable footprint while developing professionally.
Travelling: 10-20% per year.
Domicile: The Thermo Fisher domicile in Roskilde.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.
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 23.9.2020, 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
Lignende jobs
-
Teknisk assistent til HSE-området hos Novo Nordisk...
Teknisk assistent til HSE-området hos Novo Nordisk EngineeringEr du passioneret omkring organisering, systematisering og har en teknisk interesse? Så har vi en spændende mulighed til dig!Hv..Få mere info- Øvrige
- Kalundborg
-
Vil du hjælpe [xxxxx]s kunder hurtigt videre fra b...
Job-ID: 27388 Er du dygtig til at fornemme en kundes behov? Brænder du for at jagte leads? Og kan du sikre en effektiv og tryg proces fra spirende købelyst til gennemført boliglån? Så er du..Få mere info- Øvrige
- Roskilde
-
Støtte -og kontaktperson
Genopslag: [xxxxx] søger støtte- og kontaktperson til Team Bostøtte med base i Hvalsø. Stillingen er på 37 timer og er til besættelse hurtigst muligt, senest 1.3.2025 Kan du: .Få mere info- Øvrige
- Midt-og Vestsjælland
-
Personbilsteknikere – Renault
Er du klar til at tage del i opstarten af nyt Renault eftermarked hos [xxxxx] i Roskilde? I 2025 åbner vi dørene til vores autoriserede Renault værksted, og vi søger derfor to dygtige kolleg..Få mere info- Øvrige
- Roskilde
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 |
|---|---|
| 27. december 2024 | 48 |
| 26. december 2024 | 49 |
| 25. december 2024 | 49 |
| 24. december 2024 | 47 |
| 23. december 2024 | 48 |
| 22. december 2024 | 44 |
| 21. december 2024 | 45 |
| 20. december 2024 | 44 |
| 19. december 2024 | 42 |
| 18. december 2024 | 38 |
| 17. december 2024 | 36 |
| 16. december 2024 | 37 |
| 15. december 2024 | 33 |
| 14. december 2024 | 36 |
| 13. december 2024 | 36 |
| 12. december 2024 | 37 |
| 11. december 2024 | 37 |
| 10. december 2024 | 36 |
| 9. december 2024 | 34 |
| 8. december 2024 | 36 |
| 7. december 2024 | 35 |
| 6. december 2024 | 36 |
| 5. december 2024 | 39 |
| 4. december 2024 | 40 |
| 3. december 2024 | 42 |
| 2. december 2024 | 43 |
| 1. december 2024 | 44 |
| 30. november 2024 | 46 |
| 29. november 2024 | 47 |
| 28. november 2024 | 43 |
| 27. november 2024 | 42 |
Populære søgninger
Lignende søgeresultater
Introduktionsstilling i Intern Medicin, Hjertemedicinsk Afdeling, Kolding Sygehus, Sygehus Lillebælt
Se alle populære søgninger