Regulatory Affairs Associate Director, IVD

Job not on LinkedIn

November 22

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

💵 $164k - $205k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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GRAIL

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Healthcare Insurance • Biotechnology • Pharmaceuticals

GRAIL is a healthcare company that focuses on early cancer detection, aiming to transform the trajectory of cancer mortality. They have developed the Galleri multi-cancer early detection test, which utilizes cutting-edge methylation technology and machine learning to detect multiple types of cancers from a simple blood draw. The company collaborates closely with academic and biopharma partners to advance research and clinical expertise in precision oncology. GRAIL’s mission is to detect cancer early, making it more treatable and potentially curable, and they pursue this goal through innovative diagnostic solutions and external sponsored research projects.

501 - 1000 employees

Founded 2016

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Assist with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED). • Support the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation. • Collaborate cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product support, and change control processes. • Monitor and communicate changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. • Manage and provide direction to regulatory staff and participate in senior management meetings as a delegate when required. • Foster a work culture aligned with GRAIL’s values.

🎯 Requirements

• Minimum of 10 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries. • Regulatory affairs and IVD device experience preferred. • An advanced degree may count toward years of experience. • Direct experience with FDA regulatory submissions required. • Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred. • Background in diagnostics or biomarker development, particularly in oncology, is a plus. • Advanced scientific degree preferred. • Regulatory Affairs Certification (RAC) preferred. • Experience in pharmaceutical clinical, statistical, or regulatory settings—especially in oncology, immunology, or related fields—is a plus.

🏖️ Benefits

• Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. • Long-term incentive plan to align company and colleague success over time. • Progressive benefit package, including flexible time-off. • 401k with a company match. • Medical, dental, vision plans. • Mindfulness offerings.