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**Vice President of Quality Assurance and Regulatory Affairs**
2 months ago
We are seeking an experienced and visionary leader to join our team as Vice President of Quality Assurance and Regulatory Affairs at Triton Medical Robotics. As a key member of our executive team, you will be responsible for driving our quality and regulatory strategy, ensuring the highest standards of product quality and regulatory compliance.
Key Responsibilities- Develop and implement a comprehensive quality assurance and regulatory strategy to ensure product safety and efficacy, and support business objectives.
- Lead the development and maintenance of our quality management system, ensuring compliance with international regulations and standards.
- Collaborate with cross-functional teams to ensure quality and regulatory requirements are integrated into product development and manufacturing processes.
- Manage and lead a team of quality professionals, providing guidance and support to ensure they have the necessary skills and resources to perform their duties.
- Develop and manage the department budget, ensuring effective resource allocation and optimization.
- Establish and maintain relationships with regulatory authorities, ensuring compliance with regulatory requirements and staying up-to-date with emerging trends and regulations.
- Lead quality audits and inspections, identifying areas for improvement and implementing corrective actions.
- Develop and implement quality inspection procedures and statistical sampling plans, ensuring accurate and reliable data.
- Investigate and resolve quality issues, implementing effective corrective actions to prevent recurrence.
- Lead the product complaint process, ensuring timely and effective resolution of customer complaints.
- Direct regulatory authority submissions for marketing authorization and changes, ensuring compliance with regulatory requirements.
- Support regulatory authority post-market vigilance reporting, ensuring timely and accurate reporting of adverse events.
- 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.
- 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.
- 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).
We offer a competitive salary range of $275,000 to $325,000, depending on experience, as well as equity, benefits, and a 401(K) plan with matching. Triton Medical Robotics 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.
