Head of Regulatory USA (virtual/home based)

Job description

SkinVision is on a mission to save 250k lives in the next decade by revolutionising the way we care about your skin. Our technology empowers people to manage their skin health, enabling an efficient connection between users and the health system through a sophisticated yet easy to use mobile application available for download on any smartphone. With over 800k active users and more than 25k users joining us every month, we are constantly looking to grow our team with professionals who are driven by purpose and are challengers by nature.

We are looking for a Head of Regulatory (US FDA Medical Device) - home/virtual based to join our team of diverse and talented colleagues. This position plays a central role in ensuring market access of SkinVision in US and select global markets, expanding our reach to the highest number of users. Are you looking to bring your experience into an entrepreneurial and innovative environment? This might be the perfect opportunity for you. 

Job requirements

The Head of Regulatory USA is responsible for the establishment of standards and processes in the area of regulatory compliance and quality system operations necessary to maintain compliance. You will collaborate with multiple functional areas, such as Marketing, Finance and Development to direct internal resources and to 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 and educating our internal partners on best practices from a quality point of view.

Daily Drivers

  • Managing the day-to-day activities and priorities of Quality and Regulatory

  • Manage resource deployment for the Quality organisation to achieve the Quality Objectives and the maintenance of regulatory compliance

  • Lead the FDA approval process

  • 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

  • Establish quality system processes, procedures and record creation and retention in conformance with quality system regulation requirements and US regulations

  • Advise the Management Team on access and reimbursement matters in USA per state per HIC 

What you will bring in
  • Minimum education: Master degree preferably in Technology, Biotechnology, or in a related discipline, with an affinity for regulations

  • Experience with FDA submissions is mandatory, preferably PMA or DeNovo and negotiating and interacting directly with FDA 

  • Minimum 5 years working experience in Regulatory and Compliance in the field of medical devices, preferably in Software as Medical Device (SaMD)

  • IDE study protocol / writing experience 

  • Experience with ISO 14971, 62304, 27001 or SOC1 and SOC2

  • 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 regarding insured healthcare

Not sure if you are qualified?
Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women tend to only apply only when they check every box. If you feel energised by our mission and would like to use your first-class talent to accelerate the growth of SkinVision but don't necessarily meet every single point on the job description, please still apply. We'd love to receive your application and see if you could be a good fit.