Vice President of Quality Assurance and Regulatory Affairs
4 weeks ago
Neptune Medical is a Silicon Valley-based, venture capital-funded medical device start-up. We are seeking an experienced Vice President of Quality Assurance and Regulatory Affairs to join our team.
Job Summary:The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in managing quality systems and regulatory compliance for medical devices. The successful candidate will be responsible for developing and implementing quality assurance and regulatory strategies to ensure product safety and efficacy, and for leading the quality and regulatory affairs team.
Key Responsibilities:- Develop and implement quality assurance and regulatory strategies to ensure product safety and efficacy
- Lead the quality and regulatory affairs team
- Manage quality systems and regulatory compliance for medical devices
- Develop and implement corrective and preventive actions to address quality and regulatory issues
- Collaborate with cross-functional teams to ensure quality and regulatory requirements are met
- BS in engineering or scientific discipline
- Minimum 15 years of medical devices quality assurance and regulatory experience
- Minimum 10 years of experience in Director and VP roles
- Experience with bringing a product through a full regulatory cycle
- Experience with complex capital equipment as well as disposable medical devices
- Experience with electromechanical software-controlled medical devices (E.g., robotics)
- Experience with software development life cycle controls (IEC 62304)
- Experience with medical electrical equipment safety standards (IEC 60601 series)
- Experience with medical device usability evaluation (IEC 62366 series)
Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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