VP of Quality Assurance and Regulatory Affairs

2 dage tilbage

Virksomhed
Arbejdssted
Ballerup
Oprettet
21. juli 2017
Udløber
20. august 2017
Ref
85774
Kontakt
Jacob Philipsen - Tlf. +45 2024 9000
Jobtype
Fastansættelse

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 abnormalities. The
ADVATx ® laser treatment system has been cleared for sale in Europe (MD class IIb) and the US (510(k)), and we are now ramping up production. Our Quality Management System is certified according to ISO 13485:2003, MDD Annex II, and the South Korean GMP standard.
To take our quality management to the next level, we seek an experienced and dedicated VP of Quality Assurance and Regulatory Affairs.

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Job profile:
Reporting to our CEO, your tasks will be highly diversified and will include

  • Overall responsibility for our Quality Management System
  • Day-to- day management of key procedures, such as management review, CAPA, ECR, FAR, internal and external audits etc.
  • Upgrade of our system to obtain certification according to ISO 13485:2016
  • Maintenance of our quality certificates and product approvals and establishment of additional certificates and approvals required to market ADVATx in new territories
  • Overall responsibility for Regulatory Affairs
  • Ensuring compliance of product development and approval/clearance for new products
  • Close collaboration with internal and external stakeholders - such as regulatory bodies, customers, clinical partners, distributors, service partners, and suppliers – to ensure compliance and quality
  • Inciting a strong quality culture in our growing organisation
  • 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 quality management in a regulated industry
  • An M.Sc. or B.Sc. degree in engineering or other technical background
  • Experience from a high-tech manufacturing company
  • Oral and written fluency in English

Furthermore, the ideal candidate would have

  • Experience with ISO 13485, ISO 14971, and FDA 21 CFR 820
  • Experience with regulatory approval of medical devices
  • 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, we offer flexible working hours and a strong influence on how your job is carried out.

Work location: Advalight, Brydehusvej 30, Ballerup, Copenhagen, Denmark
Working hours: Full time
Salary: According to qualifications

Contact:
For more information, you are welcome to contact CEO Jacob Philipsen at (+45) 2024 9000 or visit www.advalight.com. Send your application as soon as possible via the "Ansøg" link.

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