Vice President of Quality Assurance and Regulatory Affairs

4 weeks ago

Burlingame, California, United States Triton Medical Robotics Full time

Job Title: Vice President of Quality Assurance and Regulatory Affairs

Job Summary:

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.

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 manage 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 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 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.

Requirements:

  • 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 Qualifications:

  • Experience with electromechanical software-controlled medical devices (e.g., robotics).
  • Experience with software development life cycle controls (IEC).
  • 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).

Location: Burlingame, CA

Salary: $275,000 - $325,000 per year, depending on experience

Benefits: 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.

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