Vice President of Quality Assurance & Regulatory Affairs

Neptune Medical is a Silicon Valley based, venture capital funded, medical device start-up. Using our proprietary Dynamic Rigidization technology we are designing, building, and commercializing category-defining next-generation manually and robotically operated systems for flexible endoscopy. We have a fantastic team, technology, and investors.

Title: Vice President of Quality Assurance & Regulatory Affairs

POSITION SUMMARY:

The company is seeking an experienced VP of QA & RA. The individual will be a core part of the executive team and responsible for determining and achieving the company’s quality and regulatory goals.

In this role, you will maintain and improve the quality system and design control processes for the existing (manually operated) commercial product while also implementing and building out design controls and quality processes for the in-development robotic platform.

You will have responsibility for ensuring high quality products and quality management system processes to support clinical and commercial use of company products. You will serve as the Quality System Management Representative, including hosting regulatory authority audits, and Person Responsible for Regulatory Compliance (PRRC).

Additionally, in this role you will coordinate and work with a number of outside regulatory consultants to implement Neptune’s regulatory strategy across its diverse product lines.

The ideal candidate will display the ability to perform with a high level of individual responsibility and leadership. This leader will act with passion, intensity, integrity, inventiveness, and urgency as the leader of a VC-funded medical device start-up that is fast-paced, collaborative, and driven to change standards for medical care. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to an existing commercial product line and a genuinely new type of medical robotic platform.

Essential Job Duties and Responsibilities:

• Develop, implement, and maintain the company’s quality assurance and regulatory strategy to ensure product safety and efficacy and support business objectives.
• Ensure that staff are recruited, hired, trained, managed and led to meet current and future requirements.
• Generate, and managing to, the department budget.
• 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.
• Hands-on responsibility for quality management system and regulatory compliance, including, but not limited to: document control, design control, risk management, verification/validation, manufacturing controls, personnel training, quality audits, supplier evaluation, equipment calibration/maintenance, product inspection/testing, nonconforming product control, product complaints, post-market surveillance, corrective/preventive actions, environmental monitoring, product sterilization, product installation, and product servicing.
• Lead periodic management reviews and report to top management on quality system performance and any need for improvement.
• Manage internal quality audits and external regulatory inspections.
• Establish quality inspection procedures and statistical sampling plans. Ensure that appropriate inspection and test equipment is obtained and properly used for inspections and tests.
• Lead nonconforming product review activities to efficiently disposition affected material.
• Investigate causes of nonconforming products and implement effective corrective actions.
• Lead the product complaint process.
• Direct regulatory authority submissions for marketing authorization and changes.
• Support regulatory authority post-market vigilance reporting.
• Analyze product complaint and post market surveillance data and prepare summary reports.
• As the Person Responsible for Regulatory Compliance, ensure conformity of devices and company’s compliance with applicable state, federal, and international regulations and standards.
• Recruit and manage an appropriate mix of internal staff and consultants to supply appropriate expertise and bandwidth to execute the regulatory strategy

Required 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.
• Experience with bringing a product through a full regulatory cycle.
• Experience with complex capital equipment as well as disposable medical devices.
• 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.
• Proficient with application of statistical techniques for manufacturing and quality systems.
• Excellent oral communication, written communication, and presentation skills.
• Experience recruiting, managing, retaining, motivating and leading diverse, high-performance teams, creating a workplace where team members do their best work in pursuit of an ambitious vision.
• Willingness to work hard with a strong desire to succeed as an individual and as a team leader.
• Ability to work effectively with the CEO, board of directors and senior management team.
• Ability to stay ahead of pending regulation, guidance and standards revisions, deadlines, and trends.
• Ability to drive decisions around changes and improvements by considering the tradeoffs.
• Experience with FDA and EU MDR regulatory processes.

Preferred Experience and 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).
• Experience with medical device capital equipment servicing.
• Experience with advanced catheter manufacturing.
• Experience with sterile disposables and consumables.
• Hands on experience supporting advanced catheter manufacturing is highly desirable.
• Experience with, and comfort within, a fast-growing start-up.
• Experience as a pivotal part of a team that developed products from invention to scaled market release.
• Certification by recognized quality organizations (e.g., ASQ - American Society for Quality).

Our headquarters is in Burlingame, CA adjacent to the Millbrae BART and Caltrain stations. We are primarily a work from office company.

The starting base salary for this role is between $275,000 and $325,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

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.