Vp Global Regulatory & Quality Lead

The Position
The VP Global Regulatory & Quality Lead is responsible for overseeing and managing all aspects of quality and regulatory affairs for Veracyte's global operations. This position requires a highly experienced professional with quality and regulatory experience in both domestic and international markets, specifically with the diagnostics industry. The successful candidate will have a strong background in quality and regulatory environments, including both laboratory developed tests and in vitro diagnostics (IVDs) with a deep understanding of US and European regulations and experience with the FDA and European Union notified bodies. The VP Global Quality and Regulatory Lead will play a critical role in ensuring adherence to quality management systems and compliance with regulatory requirements required for the successful launch and commercialization of Veracyte's products worldwide. This position is a hybrid role, based out of the San Diego or South San Francisco.
Responsibilities:

• Lead, manage and develop the global quality and regulatory team into a high functioning and high performing team to support Veracyte's rapid growth
• Evolve and scale our global quality and regulatory strategy to support the successful commercialization of Veracyte's products in domestic and international markets.
• Serve as the primary point of contact for all regulatory agencies, notified bodies, and other relevant stakeholders, ensuring effective communication and collaboration.
• Stay up-to-date with evolving regulatory requirements and industry trends, particularly in Europe, and provide guidance to internal teams on compliance matters.
• Lead the preparation, submission, and maintenance of regulatory filings, including pre-market approvals, 510(k) submissions, and CE marking applications.
• Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into product development plans and design control processes.
• Conduct regulatory assessments and gap analyses to identify potential risks and develop mitigation strategies.
• Provide regulatory guidance and support to Veracyte's quality management system, ensuring compliance with applicable regulations and standards.
• Participate in regulatory audits and inspections, both internally and externally, and drive the implementation of corrective and preventive actions as needed.
• Establish and maintain strong relationships with regulatory authorities, industry associations, and key opinion leaders to influence regulatory policies and advocate for Veracyte's interests.
• Stay informed about emerging regulatory issues and proactively address potential challenges that may impact Veracyte's business.

Who You Are:

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• Minimum of 15 years of regulatory experience in the diagnostics industry, with a focus on in vitro diagnostics or single site PMA or 510(k)
• Experienced managing, recruiting and retaining a high performing global team
• Extensive knowledge of domestic and international quality systems, including ISO, FDA and notified bodies for IVDR
• Strong understanding of European regulations, including the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
• Experience in additional Global Regulatory bodies, e.g. China, is preferred
• Proven experience in successfully leading regulatory submissions and obtaining regulatory approvals in multiple markets.
• Familiarity with U.S. regulatory requirements for IVDs, including FDA regulations and guidance documents.
• Experience working with notified bodies and regulatory agencies, both in the U.S. and internationally.

Preferred qualifications

• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Strong analytical and problem-solving abilities, with a keen attention to detail.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
• Flexibility to perform other duties as assigned by the Chief Medical Officer to meet the ongoing needs of the organization.

What We Can Offer You
Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are proud to have been named a "Bay Area Top Workplace" for ten years in a row by the Bay Area News Group, based solely on employee feedback.
The anticipated base salary range in the United States is $260,000 - $357,500 per year. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units.
Veracyte is a multi-state employer, and this salary range may not reflect positions that work in other states.