We are seeking a Director of Quality and Regulatory Affairs to join our team. This position reports to the company’s CEO and will work collaboratively with all stakeholders in the organization. Join our startup at the ground floor to lead our global product quality and regulatory efforts. In this role, the Director of Quality and Regulatory will provide quality and regulatory leadership across key departments in the development of hardware and software medical devices. In joining our team, you’ll enjoy competitive compensation and a creative and flexible work environment.
The Director of Quality and Regulatory Affairs shall solely be responsible for performing the duties of, and acting as, the Quality and Regulatory unit of the company by performing the following responsibilities:
Extensive working knowledge of ISO 13485:2016, IEC 62304, QSR, and Class II+ regulatory pathways
A thorough understanding of cGMP and FDA & MDR guidelines for Class II+ products
Comprehensive knowledge of electronic hardware and software-based development and manufacturing practices
5+ years regulatory compliance/quality systems/regulatory submissions experience with digital medical devices, electronic hardware, and embedded and mobile software
Extensive experience working with the FDA and international agencies regarding new product registration requirements, inspections, submissions and follow up
A degree in a science or engineering discipline (preferably an educational background in electrical, industrial, mechanical, or healthcare engineering
Self-sufficient and able to work and make decisions independently
Strong analytical and problem-solving skills
High attention to detail including proven ability to manage multiple, competing priorities simultaneously
Collaborative, team-first attitude – maximizing team performance and value ideas on their merits
Ability to collaborate with team members under pressure and iterate quickly
Strong interpersonal and leadership skills
Superior verbal and written communication skills