Job Description

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte whether it be in one of our labs, corporate offices, the field enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a results-driven environment that values innovation, collaboration, and compassion.

The Position:

We are looking for an energetic and self-motivated Regulatory Affairs professional who will provide global regulatory expertise and strategic leadership to our IVD product development teams. This position is focused on pre-market development activities with a key focus on in vitro diagnostic systems including assay, software and hardware. This role also offers the opportunity to work alongside the IVD Quality team in the development and implementation of processes for the regulatory affairs department that comply with internal, domestic, and international quality regulations.

The position requires a person with commitment to excellence, and the ability to work in a fast-paced, technically skilled, team setting.

This is a hybrid role (in office at least 3 days a week) and is based out of our headquarters in South San Francisco (SSF), California, United States. The Regulatory Affairs Manager or Sr Manager will report to the Senior Director of Global Regulatory Affairs (located in the EU) and will be a key member of the global RA department.

• Seeks expert advice and develops device regulatory product strategies and identifies data and information requirements as needed by the project.
• Key RA representative and leader on product development teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of IVD regulatory submissions, compliant with the appropriate regional or national regulations.
• Provides regulatory guidance to product development teams regarding design, development, validation and risk management.
• Manages the preparation of technical documents for review by regulatory bodies, and revises these to enable effective presentation of data and strategy to regulatory agencies.
• Supports third party on-site audits and inspections
• Stays abreast of regulatory procedures and changes in regulatory climate. Within the Global RA team, analyzes legislation and guidance and shares updates to organization under limited supervision.
• Develops, implements and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in internal initiatives to Veracyte Global Regulatory Affairs.
• Develops and assists in implementing and maintaining regulatory processes in accordance with IVDR, MDSAP etc.
• Represents RA on project initiatives with other groups to drive efficiencies across the company.

Who You Are:

• Required Education: Bachelors degree in pharmacy, biology, chemistry, pharmacology, or related life sciences
• Required Experience: 5+ years of regulatory experience in IVD, companion diagnostics, medical devices (Preferred experience: 7+ years of pre-market regulatory experience in IVD industry)
• Demonstrated hands-on experience in preparing regulatory clearance/approvals for IVD products in the EU, USA, OUS; (Preferred experience: working experience with IVD submissions under IVDR Regulations is highly desirable)
• Solid working knowledge of global regulatory requirements related to in-vitro diagnostics systems, laboratory automation and software / hardware components of IVD medical devices.
• Strong communication skills, both oral and written.
• Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts on complex projects.
• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment.
• Able to work with minimal supervision in a fast-paced environment
• Proficient in Microsoft Office Suite.

Location:

• This full-time position is located in South San Francisco (hybrid, 3 days in office)
• Minimum travel requirements, up to 10% domestic travel if required
• This position reports to the Senior Director of Global Regulatory Affairs who resides in the EU

#LI-Hybrid

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.

Pay range

$148,400$162,400 USD

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 thrilled to be recognized as a 2024 Certified Great Place to Work in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The companys growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The companys tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracytes exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. Veracyte is based in South San Francisco, California. For more information, please visit and follow the company on X (Formerly Twitter) .

Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice .

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