Remote Regulatory Affairs Manager: IVD/CDx Submissions

Regulatory Jobs; Marlborough (MA); Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical/Prescription Drugs

Dental

Vision

FSAs

401(k) Plan – Company match

Job summary

Regulatory Jobs is seeking a remote Regulatory Affairs Manager to oversee global regulatory tasks, including submissions, technical files, and registrations, driving market growth worldwide. You will collaborate with cross-functional teams and external partners to ensure compliant and timely regulatory strategies.

The role emphasizes leadership, regulatory expertise in US FDA and international agencies, and the ability to manage complex projects with strong communication.

Qualifications

• Minimum of Bachelor’s degree in a relevant healthcare/scientific field.
• A minimum of 4 years of direct experience in preparing in vitro diagnostic (IVD) regulatory submissions including PMAs, De Novo Requests, 510(k)s and/or IDEs is required.
• Experience with Immunohistochemistry (IHC) assays, oncology assays, or companion diagnostics is a plus.
• A minimum of 7 years of related experience is required with a Bachelor's degree, OR, a minimum of 5 years of related experience is required with a Master's degree or higher.

Responsibilities

• Serve as regulatory lead for companion diagnostic (CDx) programs and prepare joint regulatory submissions (510(k), PMA, IDE, Technical Files) for US FDA and international agencies.
• Coordinate with pharmaceutical partners to align regulatory strategies and timelines for submissions.
• Evaluate proposed premarket and post-market changes for regulatory impact with minimal supervision.
• Review regulatory protocols, reports, and data for compliance with health authority requirements.
• Review labels, labeling, advertising and promotional materials for regulatory compliance.
• Maintain knowledge of existing and emerging regulations and provide guidance to cross-functional teams.
• Compile and review regulatory submissions for completeness and quality, ensuring conformity with submission standards.
• Log, track, and file correspondence and submissions to regulatory authorities; ensure commitments are fulfilled.
• Identify and draft SOPs/Working Practices for Regulatory Affairs.

Skills

Regulatory strategy

Leadership

Regulatory knowledge

Project management

Communication

Attention to detail

Problem solving

Team collaboration

Time management

MS Office proficiency

Education

Bachelor’s degree in healthcare/scientific field

Master’s degree or higher

Regulatory Affairs Certification (RAC) - preferred

Tools

MS Word

Excel

PowerPoint

Job description

Regulatory Jobs is seeking a remote Regulatory Affairs Manager to oversee global regulatory tasks, including submissions, technical files, and registrations, driving market growth worldwide. You will collaborate with cross-functional teams and external partners to ensure compliant and timely regulatory strategies.

The role emphasizes leadership, regulatory expertise in US FDA and international agencies, and the ability to manage complex projects with strong communication.