Remote Regulatory Affairs Lead for CDx & IVD Submissions

Quest Diagnostics Incorporated; Marlborough (MA); Remote; USD 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental and vision insurance

401(k) plan with company match

Employee Stock Purchase Plan (ESPP)

Educational assistance

Paid time off

Zusammenfassung

Quest Diagnostics Incorporated is seeking a Regulatory Affairs Manager for global regulatory submissions, including CDx programs, PMAs, 510(k)s and IDEs. This remote role collaborates with cross-functional teams to drive regulatory strategy and market growth.

The role requires a Bachelor's degree with 4+ years in regulatory submissions for IVDs, plus experience with IHC assays and oncology CDx projects is a plus. RAC is preferred; US/EU regulatory exposure is beneficial.

Qualifikationen

• Bachelor's degree in a healthcare/scientific field (Required).
• 4+ years of direct experience in preparing in vitro diagnostic (IVD) regulatory submissions (PMA, De Novo, 510(k), IDE).
• Experience with IHC assays, oncology assays, or CDx is a plus.
• 7+ years related experience with a Bachelor's, OR 5+ years with a Master's degree or higher.

Aufgaben

• Serve as regulatory lead for CDx programs and prepare joint regulatory submissions for US FDA and international agencies.
• Coordinate with pharmaceutical partners to align regulatory strategies and timelines.
• Evaluate regulatory impact of proposed premarket and postmarket changes.
• Review protocols, reports and data for compliance with health authority requirements.
• Review labels and promotional materials for regulatory compliance.
• Maintain knowledge of regulatory regulations and provide interpretive guidance to cross-functional teams.
• Assemble and review regulatory submissions for completeness and quality.
• Log and track correspondence and submissions with authorities; ensure actions are closed.
• Draft SOPs or working practices for Regulatory Affairs.

Kenntnisse

Regulatory leadership

Project management

Communication skills

Team collaboration

Attention to detail

Problem solving

Ausbildung

Bachelor's degree

Tools

MS Word

Excel

PowerPoint

Jobbeschreibung

Quest Diagnostics Incorporated is seeking a Regulatory Affairs Manager for global regulatory submissions, including CDx programs, PMAs, 510(k)s and IDEs. This remote role collaborates with cross-functional teams to drive regulatory strategy and market growth.

The role requires a Bachelor's degree with 4+ years in regulatory submissions for IVDs, plus experience with IHC assays and oncology CDx projects is a plus. RAC is preferred; US/EU regulatory exposure is beneficial.