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VP of Quality Assurance and Regulatory Affairs

TeesuVac is a start-up that develops medical devices for utilisation in soft tissue needle biopsy. We seek an experienced and dynamic VP of Quality Assurance and Regulatory Affairs. We are located in DTU Science Park, 2970 Hørsholm.

The Job

You will be responsible for leading activities towards certification of our Quality Management System according to ISO 13485 and MDD 93/42/EEC, MDR, and to gain regulatory approval in Europe (MD class IIb) and the US (510(k)). Your tasks will be highly diversified and will include supporting production setup in a cross-functional multidisciplinary project team and interact with external quality organizations.

Job profile:

  • Overall responsibility for our Quality Management System and Regulatory Affairs
  • Certification and maintenance of our Quality Management System
  • Management of key procedures, including development procedures, internal and external audits, etc.
  • Ensuring compliance of product development and approvals required to market our biopsy devices
  • Close collaboration with internal and external stakeholders including regulatory bodies, contract manufacturers, suppliers, and to ensure compliance and quality

Candidate profile:

  • Documented experience in quality management in a regulated industry and experience with ISO 13485, ISO 14971, FDA 21 CFR 820, MDD, MDR
  • An M.Sc. or B.Sc. degree in engineering or other technical background
  • Experience working with foreign contract manufacturers and suppliers
  • Knowledge about sterilization of medical devices is an advantage
  • Fluency in spoken and written English and Danish, and excellent communication skills

Additionally, you should possess a strong personal drive, and you should be persistent and thrive while working in a start-up environment. Finally, we expect you to be a flexible colleague with the ability to overview multiple tasks, while ensuring quality, and good collaboration.

We offer

A unique and challenging job in a small entrepreneurial organization where you will come across every opportunity to develop your skills further, and you will have a high level of responsibility while working on an exciting new medical device that makes a difference. You will be part of a dedicated team embarked on an exciting journey. Working hours is full time and salary according to qualifications.

How to apply

If you are interested in the position, then please apply as soon as possible. We will invite candidates for interviews on a recurring basis. Please send you’re application and CV to e-mail job@teesuvac.com

When you send a job application to TeesuVac, it is important to inform you of our policy regarding the processing of personal data; please see our Personal Data Policy regarding recruitment on www.teesuvac.com

For more information, you are welcome to contact CEO John Hvidkjær at (+45) 6155 8399 or visit www.teesuvac.com.