**Vice President of Quality Assurance and Regulatory Affairs**
5 days ago
About Neptune Medical
Neptune Medical is a pioneering medical device company that is revolutionizing the field of flexible endoscopy with its proprietary Dynamic Rigidization technology. As a venture capital-funded start-up, we are committed to delivering innovative solutions that transform the way medical procedures are performed.
Job Summary
We are seeking an experienced Vice President of Quality Assurance and Regulatory Affairs to join our executive team. This key role will be responsible for driving the company's quality and regulatory strategy, ensuring the development and implementation of effective quality management systems, and maintaining compliance with regulatory requirements.
Key Responsibilities
- Develop and Implement Quality Strategy: Develop, implement, and maintain the company's quality assurance and regulatory strategy to ensure product safety and efficacy and support business objectives.
- Lead Quality Management System: Ensure that staff are recruited, hired, trained, managed, and led to meet current and future requirements. Generate and manage the department budget.
- Regulatory Compliance: Work closely with product development and manufacturing staff to ensure adherence to quality assurance procedures and requirements and to ensure that products meet reliability and quality expectations, including international quality management system regulations and ISO 13485.
- Quality Audits and Inspections: Manage internal quality audits and external regulatory inspections. Establish quality inspection procedures and statistical sampling plans.
- Corrective Actions: Investigate causes of nonconforming products and implement effective corrective actions. Lead the product complaint process.
- Regulatory Submissions: Direct regulatory authority submissions for marketing authorization and changes. Support regulatory authority post-market vigilance reporting.
- Team Leadership: Recruit and manage an appropriate mix of internal staff and consultants to supply appropriate expertise and bandwidth to execute the regulatory strategy.
Requirements
- Education and Experience: BS in engineering or scientific discipline. Advanced degree preferred. Minimum 15 years of medical devices quality assurance and regulatory experience. Minimum 10 years of experience in Director and VP roles.
- Skills and Qualifications: Proficient with the design, implementation, and maintenance of quality management systems for medical device development, manufacturing, distribution, and post-market surveillance. Proficient with international medical device regulations and standards. Excellent oral communication, written communication, and presentation skills.
- Preferred Qualifications: 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).
What We Offer
Neptune Medical provides a competitive salary range of $275,000 to $325,000 depending on experience. This role may also be eligible for equity, benefits, and 401(K) with matching. We are an equal employment opportunity employer and prohibit 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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