Sr. Scientist, Regulatory Liaison
Merck
August 20, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Position Overview
Under the direction of the Executive Director, Regulatory Digital Health, assist in driving the strategy for the Digital Health Medical Device Modality with Global Regulatory Leads (GRLs), CMC scientists, Pharmacovigilance (PV), Global Labeling (GL), and other functions.
Primary Duties/Assignments
- Support communication and assessment of the emerging regulatory landscape; drive cross-functional implementation of device/digital health requirements across GRACS.
- Advise assigned Global Regulatory Teams (GRTs) on device and digital health aspects and share leading practices.
- Contribute to digital health planning and establish processes to incorporate device/digital health into ways of working across the portfolio.
- Build and maintain processes to support key activities/initiatives.
- Collaborate with Research, Manufacturing, Commercial, and IT to align regulatory requirements for successful registrations.
- Conduct policy reviews; support risk management and audit/assessment activities.
- Develop best-practice guidance for digital health regulatory deliverables.
- Facilitate internal/external discussions; independently manage lower-to-moderate complexity initiatives (milestones, risks, issues, dependencies, escalation).
- Conduct independent research/gap analysis; communicate clearly in written/verbal formats; influence without authority.
Education
- Minimum: Bachelor’s degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related.
- Preferred: Advanced degree and/or RAPS RAC, ASQ Quality, or Scrum certifications.
Required Experience/Skills
- Knowledge of global drug/device regulatory requirements and emerging landscape.
- Awareness of digital health technologies in drug development/biopharma.
- Strong independent execution; analytical problem solving; interpretation into actionable recommendations.
- Cross-functional collaboration; excellent communication/presentation.
- Ability to work in ambiguity; ownership/accountability/initiative; curiosity to learn.
- At least 2 years relevant experience (device/biological/pharmaceutical research or compliance/manufacturing/testing/quality/regulatory affairs).
Required Skills (high level)
Regulatory strategy/submissions, regulatory compliance & communications, filings, reporting, process improvement, stakeholder management, strategic thinking, team training, working independently.
Benefits/Pay (as stated)
- Salary range: $117,000.00–$184,200.00. Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits include medical/dental/vision, retirement (401(k)), paid holidays/vacation, and compassionate/sick days.
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline: stated on the posting (Job posting end date: 08/28/2026).
Under the direction of the Executive Director, Regulatory Digital Health, assist in driving the strategy for the Digital Health Medical Device Modality with Global Regulatory Leads (GRLs), CMC scientists, Pharmacovigilance (PV), Global Labeling (GL), and other functions.
Primary Duties/Assignments
- Support communication and assessment of the emerging regulatory landscape; drive cross-functional implementation of device/digital health requirements across GRACS.
- Advise assigned Global Regulatory Teams (GRTs) on device and digital health aspects and share leading practices.
- Contribute to digital health planning and establish processes to incorporate device/digital health into ways of working across the portfolio.
- Build and maintain processes to support key activities/initiatives.
- Collaborate with Research, Manufacturing, Commercial, and IT to align regulatory requirements for successful registrations.
- Conduct policy reviews; support risk management and audit/assessment activities.
- Develop best-practice guidance for digital health regulatory deliverables.
- Facilitate internal/external discussions; independently manage lower-to-moderate complexity initiatives (milestones, risks, issues, dependencies, escalation).
- Conduct independent research/gap analysis; communicate clearly in written/verbal formats; influence without authority.
Education
- Minimum: Bachelor’s degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related.
- Preferred: Advanced degree and/or RAPS RAC, ASQ Quality, or Scrum certifications.
Required Experience/Skills
- Knowledge of global drug/device regulatory requirements and emerging landscape.
- Awareness of digital health technologies in drug development/biopharma.
- Strong independent execution; analytical problem solving; interpretation into actionable recommendations.
- Cross-functional collaboration; excellent communication/presentation.
- Ability to work in ambiguity; ownership/accountability/initiative; curiosity to learn.
- At least 2 years relevant experience (device/biological/pharmaceutical research or compliance/manufacturing/testing/quality/regulatory affairs).
Required Skills (high level)
Regulatory strategy/submissions, regulatory compliance & communications, filings, reporting, process improvement, stakeholder management, strategic thinking, team training, working independently.
Benefits/Pay (as stated)
- Salary range: $117,000.00–$184,200.00. Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits include medical/dental/vision, retirement (401(k)), paid holidays/vacation, and compassionate/sick days.
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline: stated on the posting (Job posting end date: 08/28/2026).