VP QA & RA
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Ballerup
On behalf of Advalight in Ballerup, People In Action is looking for a
VP QA & RA for Medical Laser Company
Join a start-up bringing world-class laser innovation to dermatology
Advalight has developed a patented, multi-wavelength, medical laser system allowing dermatologists to treat a wide variety of skin conditions. The ADVATx® laser system has been cleared for sale in Europe (MDR class IIb), the US (510(k)), as well as in a range of Asian countries, and we are now ramping up production and sales. Our Quality Management System is certified according to ISO 13485, MDR annex II, and the South Korean GMP standard.
To take our regulatory affairs and quality management to the next level, we seek an experienced and dynamic VP of Quality Assurance and Regulatory Affairs.
Job profile:
Reporting to our CEO, your tasks will be highly diversified and will include:
You will furthermore be a part of the Advalight management team and are expected to contribute to the overall development of our company.
Candidate profile:
Your qualifications should include:
Furthermore, the ideal candidate would have
You will be part of a dedicated team embarked on an exciting growth journey, where time is of essence. Therefore, we expect you to be a flexible co-worker with a strong sense of urgency and the ability to overview multiple tasks, while keeping up quality, structure, and good teamwork. In return, you are offered flexible working hours and a strong influence on how your job is carried out.
Are you interested?:
Applications are evaluated continuously.
VP QA & RA for Medical Laser Company
Join a start-up bringing world-class laser innovation to dermatology
Advalight has developed a patented, multi-wavelength, medical laser system allowing dermatologists to treat a wide variety of skin conditions. The ADVATx® laser system has been cleared for sale in Europe (MDR class IIb), the US (510(k)), as well as in a range of Asian countries, and we are now ramping up production and sales. Our Quality Management System is certified according to ISO 13485, MDR annex II, and the South Korean GMP standard.
To take our regulatory affairs and quality management to the next level, we seek an experienced and dynamic VP of Quality Assurance and Regulatory Affairs.
Job profile:
Reporting to our CEO, your tasks will be highly diversified and will include:
- Overall responsibility for Quality Assurance & Regulatory Affairs
- Ensure to comply with regulatory requirements when entering new markets
- Prepare & ensure document packages for regulatory submissions for new products and current
- Maintain “license to operate “of our Quality Management System
- Close collaboration with key-stakeholders - such as regulatory bodies, customers, clinical partners, distributors, service partners, and suppliers
- Overall management of key procedures, such as management review, NCR. CAPA, ECR, FAR, Audits etc.
- Understanding of design controls and applicable standards related to the product
- Inciting a strong quality culture in our growing organization
- Driving continuous improvement efforts aiming for high quality in everything we do
You will furthermore be a part of the Advalight management team and are expected to contribute to the overall development of our company.
Candidate profile:
Your qualifications should include:
- A proven track record of regulatory affairs and quality management in the medical device or pharma industry (min 4 years of proven experience in medical devices
- Experience from a high-tech manufacturing company
- An M.Sc. or B.Sc. degree in engineering or other technical background
- Oral and written fluency in English
Furthermore, the ideal candidate would have
- Experience with ISO 13485, MDR, ISO 14971, FDA 21 CFR 820
- Experience with software validation and process validation
- Experience from working in a start-up
- Oral and written fluency in Danish
You will be part of a dedicated team embarked on an exciting growth journey, where time is of essence. Therefore, we expect you to be a flexible co-worker with a strong sense of urgency and the ability to overview multiple tasks, while keeping up quality, structure, and good teamwork. In return, you are offered flexible working hours and a strong influence on how your job is carried out.
Are you interested?:
Applications are evaluated continuously.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 10.3.2020, 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
- Ballerup
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Statistik over udbudte jobs som øvrige i Ballerup
Herunder ser du udviklingen i udbudte øvrige i Ballerup 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.
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Statistik over udbudte øvrige i Ballerup over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 19. september 2024 | 61 |
| 18. september 2024 | 60 |
| 17. september 2024 | 61 |
| 16. september 2024 | 63 |
| 15. september 2024 | 65 |
| 14. september 2024 | 66 |
| 13. september 2024 | 67 |
| 12. september 2024 | 66 |
| 11. september 2024 | 66 |
| 10. september 2024 | 68 |
| 9. september 2024 | 66 |
| 8. september 2024 | 64 |
| 7. september 2024 | 67 |
| 6. september 2024 | 68 |
| 5. september 2024 | 67 |
| 4. september 2024 | 60 |
| 3. september 2024 | 67 |
| 2. september 2024 | 66 |
| 1. september 2024 | 67 |
| 31. august 2024 | 73 |
| 30. august 2024 | 77 |
| 29. august 2024 | 77 |
| 28. august 2024 | 75 |
| 27. august 2024 | 79 |
| 26. august 2024 | 79 |
| 25. august 2024 | 81 |
| 24. august 2024 | 82 |
| 23. august 2024 | 82 |
| 22. august 2024 | 83 |
| 21. august 2024 | 79 |
| 20. august 2024 | 78 |