Remote Regulatory Affairs Manager, Companion Diagnostics

QUEST DIAGNOSTICS INC; Marlborough (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSAs

401(k) Plan

ESPP

Life Insurance

Disability

Wellness resources

Educational Assistance

Paid time off

Job summary

Quest Diagnostics Inc. is seeking a Regulatory Affairs Manager to lead regulatory activities for companion diagnostic programs, coordinating global submissions and strategy to drive market growth worldwide.

The role involves remote work with collaboration across cross-functional teams and external partners. The candidate will manage regulatory reviews, maintain up-to-date knowledge of US and EU requirements, and ensure compliance in submissions and labeling.

Qualifications

• Bachelor’s degree in a healthcare/scientific field required.
• 4+ years of direct experience in preparing IVD regulatory submissions (510(k), PMA, IDE) required.
• 7+ years of related experience with a BA or 5+ with MS/higher.

Responsibilities

• Lead regulatory submissions for CDx programs (510(k), PMA, IDE) for US FDA and international authorities.
• Coordinate with pharmaceutical partners to align regulatory strategies and timelines.
• Evaluate regulatory impact of proposed premarket and post-market changes.
• Review protocols, reports and data for compliance with health authority requirements.
• Review labels and promotional materials for regulatory compliance.
• Maintain knowledge of existing and emerging regulations and guide cross-functional teams.
• Draft SOPs and Working Practices for Regulatory Affairs.

Skills

Regulatory leadership

Attention to detail

Time management

Communication

Team collaboration

Problem solving

Project management

Decision making

Conflict resolution

Education

Bachelor’s degree in a healthcare/scientific field

Tools

MS Word

MS Excel

PowerPoint

Job description

Quest Diagnostics Inc. is seeking a Regulatory Affairs Manager to lead regulatory activities for companion diagnostic programs, coordinating global submissions and strategy to drive market growth worldwide.

The role involves remote work with collaboration across cross-functional teams and external partners. The candidate will manage regulatory reviews, maintain up-to-date knowledge of US and EU requirements, and ensure compliance in submissions and labeling.