GRAIL

Detect cancer early, when it can be cured.

Regulatory Affairs Associate Director, IVD

ComplianceComplianceFull TimeRemoteSeniorTeam 501-1,000Since 2016H1B SponsorCompany Site LinkedIn

Location

New Jersey

Posted

116 days ago

Salary

$164K - $205K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglish

Job 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.

Job 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.