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 Manager is responsible for the establishment of standards and processes in the area of regulatory 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 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 regulatory point of view.
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
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 4 years working experience in Quality and Regulatory in the field of medical devices
Experience with FDA and ISO submissions
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