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 enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way – it’s about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions.
Our Values:
- We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
- We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
- We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
- We Care Deeply: We embrace our differences, do the right thing, and encourage each other
The Position:
We are seeking a self-driven and experienced Regulatory Affairs Manager with a strong background in the EU IVDR, including preparation of technical file submissions and all aspects of labeling. Experience in vigilance and post-market surveillance of in vitro diagnostics (IVD) would be advantageous. This role will play a key part in supporting the global expansion and lifecycle management of our IVD product portfolio which includes assay, software, and instrument components. The position will also contribute to the development of strategic regulatory processes and cross-functional initiatives aligned with international standards and regulations.
The ideal candidate thrives in a fast-paced, collaborative, and technically complex environment and is committed to ensuring compliance throughout the product lifecycle – from development through post-market.
You will report to the Senior Director of Global Regulatory Affairs (EU-based) and collaborate closely with the global Regulatory Affairs (RA) and Quality teams to ensure regulatory compliance, support product registrations globally, and contribute to vigilance and surveillance programs.
Key Responsibilities:
- Take a lead role in ensuring regulatory compliance of IVDR regulatory submissions, labeling, including instructions for use, labels and safety data sheets.
- Support IVD product development teams by providing regulatory guidance on requirements, impacting new product introductions and changes to existing products.
- Help drive post-market surveillance (PMS) and vigilance reporting activities, including adverse event tracking, complaint trending, and periodic safety update reports (PSURs), in compliance with EU IVDR and other applicable regulations.
- Collaborate in the preparation, review, and submission of technical documentation to meet IVDR, MDSAP, and other global regulatory requirements.
- Participate in and support internal and external audits, inspections, and regulatory authority interactions related to PMS and vigilance activities.
- Assist in the development and implementation of regulatory policies and procedures to ensure effective global compliance and continuous improvement within the RA function.
- Represent Regulatory Affairs in cross-functional initiatives focused on product lifecycle management, regulatory readiness, and global market access strategies.
- Support internal and external training initiatives to increase organizational awareness of global labeling, post-market and vigilance requirements.
Who You Are:
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
- Minimum of 5 years of IVD development for the EU market, labeling and regulatory affairs experience in the IVD medical device industry, with strong exposure to international regulatory submission documentation and post-market activities.
- Solid understanding of IVDR, ISO 13485, MDSAP, and other global regulatory frameworks.
- Ideally, proven experience of managing labeling, vigilance and PMS programs
- Excellent communication, analytical, and project management skills.
- Self-motivated, adaptable, and capable of working independently in a remote, globally distributed team.
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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 company’s 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 company’s 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 Veracyte’s 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 www.veracyte.com 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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