Manager, Quality Assurance & Regulatory Compliance

Neptune Medical is a venture backed medical device company based in Silicon Valley. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology. Pathfinder® is our first FDA-cleared commercial device incorporating this novel technology. This advanced endoscopy device is being used at a growing list of leading U.S. hospitals and academic medical centers. Now, the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

TITLE: Manager, Quality Assurance & Regulatory Compliance

POSITION SUMMARY:

We are seeking an experienced and skilled Manager of Quality Assurance and Regulatory Compliance to lead our organization's quality assurance and compliance efforts. This role involves developing, implementing, and maintaining quality systems and compliance policies to ensure adherence to regulatory standards. The ideal candidate will have a strong background in post-market surveillance, CAPA management, internal and external audits, and QMS maintenance.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES:

• Develop, implement, and maintain a robust QMS that adheres to international standards (e.g., ISO 13485, FDA 21 CFR 820, EU Medical Device Regulation).
• Ensure continuous improvement of the QMS through regular reviews and updates.
• Oversee critical QA projects to ensure regulatory compliance while optimizing costs and operational efficiency.
• Define and implement a forward-thinking quality system strategy aligned with business needs and global best practices.
• Drive continuous improvement initiatives, ensuring robust risk management, NC/CAPA resolution, and quality planning.
• Design and execute post-market surveillance strategies to monitor product performance and safety.
• Analyze PMS data to identify trends and implement corrective actions as needed.
• Develop, implement, and manage CAPA processes to address quality issues and prevent future occurrences.
• Ensure timely closure of CAPAs and verify effectiveness of implemented actions.
• Plan, coordinate, and conduct internal audits to assess compliance with regulatory requirements and QMS standards.
• Manage external audits by regulatory bodies or third-party auditors, ensuring readiness and effective response to audit findings.
• Ensure compliance with local and international regulations, such as FDA regulations (21 CFR 11, 21 CFR 820), EU MDR, and ISO standards.
• Stay updated on regulatory changes and implement necessary adjustments to maintain compliance.
• Design and deliver compliance training programs to educate employees on regulatory requirements and quality standards.
• Provide ongoing training to ensure continuous awareness and adherence to compliance policies.
• Maintain accurate records of quality assessments, compliance reports, and audit findings for internal and external audits.
• Prepare detailed compliance reports for senior management, highlighting areas for improvement.
• Foster a culture of excellence and continuous improvement within the quality assurance department and throughout the organization.
• Collaborate with cross-functional teams (e.g., production, engineering) to integrate quality throughout the product lifecycle.
• Communicate effectively with vendors, contractors, or suppliers to ensure their products or services meet organizational quality standards.
  
  

REQUIRED QUALIFICATIONS:

• Bachelor's degree in a relevant field, e.g., engineering, science.
• Minimum of 7 years in quality assurance and regulatory compliance, preferably in a cGMP environment.
• Prior experience in interfacing with Regulatory and Notified Bodies
• Hands on experience with CAPAs
• Understands applicability of Quality System Regulations
• Excellent communication, leadership, and analytical skills
• Detail-oriented with a strong focus on regulatory compliance.
• Ability to work independently and as part of a team.
• Strong problem-solving and decision-making abilities.
• Proactive and able to manage multiple projects simultaneously.
• Strong leadership, communication, and organizational skills.
• Excellent verbal and written communications skills including presentation of technical content.
• Willingness to work in a startup environment and adapt to changing needs and priorities.
• Proficiency in Microsoft applications.
• Eagerness to learn new things.
  
  

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Our job titles may span more than one career level. The starting base salary for this role is between $136,000 and $170,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. 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.