Director of RAQA (IVD)
Are you a visionary leader in Regulatory Affairs and Quality Assurance with deep expertise in In Vitro Diagnostics (IVD)? JRG Partners, a premier executive search firm, is partnering with a pioneering medical technology company dedicated to advancing patient care through innovative diagnostic solutions. We are seeking an exceptional Director of RAQA (IVD) to spearhead our client’s regulatory and quality strategies, ensuring global compliance and accelerating market access for their cutting-edge IVD product portfolio.
This critical leadership role offers a unique opportunity to shape the future of diagnostic medicine, working at the intersection of scientific innovation, regulatory intelligence, and quality excellence. If you are passionate about driving compliance, fostering a culture of quality, and navigating complex global regulatory landscapes to bring life-changing IVD products to market, we invite you to explore this impactful position.
Role Overview for Director of RAQA (IVD)
As the Director of RAQA (IVD), you will be the strategic architect and operational leader responsible for all regulatory affairs and quality assurance activities pertaining to our client’s in vitro diagnostic products. Reporting directly to senior leadership, you will build, mentor, and lead a high-performing team, fostering a culture of proactive compliance and continuous improvement. Your primary mission will be to develop and execute global regulatory strategies that align with business objectives, ensure adherence to international quality standards, and secure timely product registrations and approvals across diverse markets.
This role demands a comprehensive understanding of the IVD regulatory framework, including but not limited to FDA regulations (21 CFR Part 820, 809), the European In Vitro Diagnostic Regulation (IVDR), ISO 13485, and other global requirements.
You will serve as the primary liaison with regulatory bodies, lead audit preparations, and drive the continuous evolution of the Quality Management System (QMS). Beyond compliance, you will be a strategic partner to R&D, Clinical, and Commercial teams, providing expert guidance throughout the product lifecycle, from concept to post-market surveillance. Your leadership will be instrumental in maintaining the highest standards of product quality and safety, safeguarding patient well-being, and strengthening the company’s reputation as a leader in diagnostic innovation.
The successful candidate will possess a proven track record of navigating complex regulatory pathways for novel IVD devices, demonstrating strategic foresight, exceptional problem-solving abilities, and a commitment to operational excellence. This is more than a compliance role; it’s a leadership position that will directly influence the company’s growth trajectory and its ability to deliver transformative diagnostic solutions to healthcare providers and patients worldwide.
Key Responsibilities of Director of RAQA (IVD)
Global Regulatory Strategy & Submissions
Develop, implement, and execute comprehensive global regulatory strategies for IVD products, encompassing pre-market submissions (e.g., 510(k), PMA, De Novo, CE Mark under IVDR) and post-market changes. Oversee the preparation, review, and submission of high-quality regulatory dossiers to FDA, European Notified Bodies, and other international regulatory agencies.
Quality Management System (QMS) Leadership
Own and continuously improve the company’s Quality Management System (QMS) in accordance with ISO 13485:2016 and 21 CFR Part 820. Ensure all aspects of the QMS are effective, compliant, and support the product lifecycle from design and development through manufacturing, distribution, and post-market activities.
Regulatory Intelligence & Compliance
Proactively monitor, interpret, and disseminate information regarding emerging global IVD regulatory requirements, standards, and guidelines. Assess their impact on business operations and product development, and lead initiatives to ensure ongoing compliance. This includes deep expertise in the EU In Vitro Diagnostic Regulation (IVDR) and its implications.
Audit & Inspection Management
Serve as the primary point of contact and lead for all external regulatory inspections (e.g., FDA, Notified Body) and internal audits. Develop robust audit readiness plans, manage responses to findings, and ensure timely implementation of corrective and preventive actions (CAPAs).
Post-Market Surveillance & Vigilance
Establish and manage robust post-market surveillance (PMS) and vigilance systems compliant with global regulations. Oversee complaint handling, adverse event reporting, field actions, and trend analysis to ensure product safety and effectiveness throughout the product’s lifecycle.
Risk Management
Lead and facilitate the application of risk management principles across the product lifecycle, ensuring compliance with ISO 14971 and integration with design, development, manufacturing, and post-market activities.
Team Leadership & Development
Recruit, mentor, and develop a high-performing RAQA team. Foster a collaborative and accountable environment, providing guidance, training, and professional development opportunities to enhance team capabilities and engagement.
Cross-Functional Collaboration
Partner closely with R&D, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and Commercial teams to integrate RAQA requirements into product development, launch, and maintenance activities. Provide expert regulatory and quality guidance to support strategic business decisions.
Document Control & Training
Oversee document control processes to ensure accurate and accessible records. Develop and deliver comprehensive training programs on QMS procedures and regulatory requirements to relevant personnel across the organization.
Budget Management
Manage the RAQA department budget effectively, optimizing resource allocation to achieve strategic objectives.
Requirements for the Director of RAQA (IVD)
Education
Bachelor’s degree in a scientific discipline (e.g., Biomedical Engineering, Biology, Chemistry, Medical Technology) or related field. A Master’s degree or Ph.D. in a relevant discipline, or RAC (Regulatory Affairs Certification) is highly preferred.
Experience
A minimum of 10-15 years of progressive experience in Regulatory Affairs and Quality Assurance within the medical device industry, with at least 5-7 years specifically focused on In Vitro Diagnostics (IVD). A minimum of 5 years in a leadership or management role, overseeing RAQA teams and strategies.
IVD Expertise
Extensive, hands-on experience with IVD product classifications, regulatory pathways, and technical documentation requirements (e.g., Design History Files, Technical Files/Design Dossiers for IVD).
Regulatory Knowledge
In-depth knowledge and practical application experience of global IVD regulations and standards, including:
- U.S. FDA regulations (21 CFR Part 820, 809, 812)
- European In Vitro Diagnostic Regulation (EU IVDR 2017/746) and previous IVDD (98/79/EC)
- ISO 13485:2016 (Quality Management Systems for Medical Devices)
- ISO 14971 (Risk Management for Medical Devices)
- Other international regulations (e.g., Health Canada, TGA, PMDA) are a significant plus.
Submission Experience
Proven track record of successful pre-market submissions (e.g., 510(k), PMA, De Novo, CE Mark under IVDR) and post-market compliance activities. Experience interacting directly with regulatory agencies and Notified Bodies.
Leadership & Management Skills
Demonstrated ability to lead, mentor, and develop a high-performing team. Strong interpersonal skills with the ability to influence cross-functional teams and senior management.
Strategic Thinking
Exceptional strategic planning and execution skills, with the ability to translate regulatory requirements into actionable business strategies.
Communication
Excellent verbal and written communication skills, including the ability to present complex regulatory information clearly and concisely to diverse audiences.
Problem-Solving
Strong analytical and problem-solving abilities, with a proactive and solutions-oriented approach to regulatory and quality challenges.
Audit Experience
Experience leading and participating in regulatory inspections and audits.
Adaptability
Ability to thrive in a fast-paced, dynamic, and evolving environment, managing multiple priorities effectively.
Benefits & Perks Offered
Our client values its employees and offers a comprehensive and highly competitive benefits package designed to support your professional growth, personal well-being, and financial security. As the Director of RAQA (IVD), you will receive:
Competitive Salary & Bonus
An attractive base salary commensurate with experience and a performance-based annual bonus.
Equity/Stock Options
Opportunity to participate in the company’s success through equity grants.
Health & Wellness
Robust medical, dental, and vision insurance plans for you and your family, along with wellness programs.
Retirement Planning
Generous 401(k) matching program to help you build your financial future.
Paid Time Off
Ample vacation, sick leave, and company holidays to ensure work-life balance.
Professional Development
Support for continuous learning, including conference attendance, certifications (e.g., RAC), and tuition reimbursement.
Relocation Assistance
For qualified candidates seeking to relocate to the vibrant Boston area.
Collaborative Culture
A dynamic and inclusive work environment where innovation is celebrated, and your contributions are highly valued.
Impactful Work
The opportunity to play a pivotal role in bringing life-changing diagnostic products to patients worldwide.
Modern Facilities
State-of-the-art office and lab facilities designed to foster collaboration and innovation.
How to Apply
If you are a driven and experienced Regulatory Affairs and Quality Assurance leader with a passion for IVD and a desire to make a significant impact, we encourage you to apply. JRG Partners is committed to connecting top-tier talent with leading organizations. This is an exceptional opportunity to join a forward-thinking company at the forefront of diagnostic innovation.
To express your interest and learn more about this exciting Director of RAQA (IVD) opportunity, please submit your resume and a cover letter detailing your relevant experience and qualifications through our secure portal. For more information about our expertise in this sector, please visit our Life Sciences Executive Search practice area page.
JRG Partners and our client are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees.
