[Remote] Regulatory Affairs Associate Director, IVD # 4432 at GRAIL

New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, Medical Devices, Cancer DetectionIndustries

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

Responsibilities

Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies
Provide regulatory support for both new and marketed Laboratory Developed Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval
Monitor and report on international regulatory developments and LDT requirements that may significantly impact business operations or customers
Maintain up-to-date knowledge of applicable regulatory requirements and relevant scientific/technical developments
Identify regulatory risks and propose alternative courses of action
Assess new regulations and collaborate with internal teams to implement appropriate changes
Support internal and external quality audits
Ensure compliance with all regulations and laws applicable to GRAIL's business, providing guidance and recommendations
Review and approve regulatory strategy documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings
Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department
Perform other duties as assigned

Skills

Key technologies and capabilities for this role

Regulatory AffairsIVD RegulationsInvestigational Device Exemption (IDE)Premarket Approval (PMA)Regulatory StrategyPre-submissionsAnnual ReportsFDA SubmissionsNext-Generation Sequencing (NGS)Quality AssuranceAuditsChange ControlPromotional Material Review

Questions & Answers

Common questions about this position

What is the employment type for this Regulatory Affairs Associate Director role?

The position is full-time.

Where is GRAIL headquartered and what are its other locations?

GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom.

What are the key responsibilities of this role?

The role involves strategizing and authoring regulatory plans for FDA and global health authorities, preparing submissions like PMAs and 510(k)s, providing support for LDT products, monitoring international regulatory developments, and identifying regulatory risks.

What experience is needed for this Regulatory Affairs position?

Experience with regulatory strategy, FDA submissions including IDEs, PMAs, and 510(k)s, IVD requirements, and LDT products is required, along with knowledge of regulatory policies and cross-functional collaboration.

What is the company culture like at GRAIL?

The role fosters a work culture aligned with GRAIL’s values, within a multi-disciplinary organization of scientists, engineers, and physicians focused on early cancer detection.

GRAIL

Develops blood tests for early cancer detection

About GRAIL

GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.

Menlo Park, CaliforniaHeadquarters

2016Year Founded

$1,765.5MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Risks

Potential overdiagnosis could impact the perceived value of GRAIL's tests.

Significant net losses may affect investor confidence and long-term sustainability.

High test costs may limit accessibility in markets with less healthcare funding.

Differentiation

GRAIL uses high-intensity sequencing for early cancer detection via blood tests.

The Galleri test screens for over 50 cancers with a single blood draw.

GRAIL's tests are supported by large-scale clinical studies ensuring reliability.

Upsides

Collaborations with platforms like Function Health expand Galleri test accessibility.

Revenue from Galleri grew 52% year-over-year, indicating strong market demand.

GRAIL's technology aligns with trends in personalized and preventative medicine.

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