QA/RA Director

Job description

Did you know that 1 in 5 people get skin cancer during their lifetime?

At SkinVision, we are on a mission to save the lives of 250,000 people in the next ten years by revolutionizing the way we care about our skin. Our technology mobilizes and empowers consumers to act on and manage their skin health, enabling a connection between our customers and the health system to reduce this number. If you’d like to be part of a team of a rapidly growing international startup in the health sector, please read on.


The Regulatory and Compliance Director is responsible for the establishment of standards and processes in the area of regulatory and quality system operations necessary to maintain compliance. As part of the management team, you will collaborate with multiple functional areas, such as Marketing, Finance and Development to direct internal resources and coordinate with external notified bodies. This position plays a vital role in bringing our business to the next level by maintaining our compliance to national and international regulations in the e-health landscape that will allow us to deliver our long term vision. 

 

Daily Drivers 

  • Lead the QA/RA department by building and coaching team in order to prepare us for future market opportunities
  • Be the subject matter expert in the management team from a QA/RA perspective 
  • Managing the day-to-day activities and priorities of Quality and Regulatory 
  • Manage resource deployment for the Quality organization to achieve the Quality Objectives and in the maintenance of regulatory compliance

  • Guide submissions to regulatory bodies 

  • Control and continuously improve the company’s quality system in accordance with local and international regulations

  • Support the improvement our services through collaborations with other functional areas 

  • Bring knowledge of medical device development to support departmental planning activities



Requirements

What you will bring in

  • Minimum education needed is a Master degree preferably in Technology, Biotechnology, or in a related discipline, with an affinity for regulations

  • Minimum 8 years working experience in Quality and Regulatory in the field of medical devices

  • Experience with FDA, ISO and other international quality systems

  • Strong communication skills, especially in advising higher management and other internal partners on compliance matters

  • Detail oriented with an ability to notice details and patterns that might have an impact on product’s quality and liability

  • Strong analytical and problem solving skills with the ability to work with diverse groups while maintaining high degrees of integrity

  • Understanding of legal and scientific compliance matters

  • Proficiency in English both verbally and written. Knowledge of other languages are certainly a plus

  • Knowledge of legal data privacy (GDPR) framework

  • Knowledge of legal framework around health insurances