Associate Director of Regulatory Affairs, IVD - Austin - GRAIL, Inc.

Description

Join our mission to revolutionize cancer care by detecting cancer early when it can be cured. We are at the forefront of innovative health technology, utilizing next-generation sequencing, extensive clinical studies, and cutting-edge data science to tackle one of healthcare's greatest challenges.

As a pioneering healthcare company, we have formed a dynamic team of scientists, engineers, and medical professionals. Our commitment to transforming cancer detection is supported by leading investors and global partners in pharmaceuticals and technology.

The Associate Director of Regulatory Affairs will play a pivotal role in shaping regulatory strategies and developing submissions for GRAIL's innovative projects, including Multi-Cancer Early Detection (MCED). This position is vital to the U.S. Regulatory team, focusing on preparing Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), and other essential documentation.

Collaboration is key; you will work closely with Quality, Lab Operations, and various stakeholders to develop regulatory strategies, validate products, support audits, and ensure compliance with on-market products. Staying abreast of changes in regulatory policies and In Vitro Diagnostic (IVD) requirements is critical in this role, as is fostering a work culture aligned with GRAIL's values.

Responsibilities:

• Develop regulatory plans and activities to strategically position GRAIL products with the FDA and international health authorities.
• Assist in the preparation of regulatory submissions including PMAs, 510(k)s, annual reports, and establishment registrations.
• Contribute as a key member of the Regulatory team, providing insights on product portfolios and strategies.
• Offer regulatory support for new and marketed Laboratory Developed Test (LDT) products, including documentation for labeling and compliance.
• Monitor international regulatory developments that may influence business operations or client needs.
• Maintain current knowledge of relevant regulatory requirements and scientific advancements.
• Identify regulatory risks and recommend alternative strategies.
• Collaborate with internal teams to implement changes in response to new regulations.
• Support quality audits and ensure compliance with applicable laws and regulations.
• Review and align regulatory strategy documents, plans, and procedures with industry commitments.
• Oversee the creation and revision of Standard Operating Procedures within the regulatory affairs function.
• Perform additional duties as assigned.

Required Qualifications:

• A master's or PhD with over 10 years of experience in regulatory affairs, clinical affairs, or program management within the IVD, medical device, or pharmaceutical industries.
• Extensive knowledge of regulatory affairs and IVD devices is essential.
• Required experience with FDA submissions, particularly PMAs.
• Understanding of both U.S. and international regulatory processes for medical devices is necessary.
• Excellent written and verbal communication skills are essential.

Preferred Qualifications:

• Experience with regulatory submissions in EU, Japan, China, Canada, and other markets is an advantage.
• A background in diagnostics or biomarker development, particularly within oncology, is beneficial.
• Regulatory Affairs Certification (RAC) is preferred.
• Previous experience in pharmaceutical clinical, statistical, or regulatory settings in oncology or related fields is a plus.
• Demonstrated leadership and strong business partnership skills are preferred.
• A collaborative spirit in dynamic environments is a plus.
• A proactive problem-solving mindset is advantageous.
• Exceptional organizational skills and attention to detail are preferred.

Physical Demands and Environment:

• Work hours and days may vary based on operational needs.
• Prolonged standing or sitting may be necessary.
• Some lifting (up to 25 pounds) may be required.
• Occasional travel to GRAIL offices or other locations is expected to perform work or attend events.

The expected full-time annual salary for this position is between $164K and $205K, dependent on skills and experience. This position may also be eligible for bonuses and other forms of compensation.

GRAIL is an equal opportunity employer, committed to fostering a diverse and inclusive workplace. We encourage all qualified candidates to apply, regardless of race, color, religion, gender, sexual orientation, age, disability, or any other protected characteristic. If you require accommodations for the application process, please let us know.

We maintain a drug-free workplace and invite job-seekers from all backgrounds to be part of our team