Responsibilities:
- Support communication and assessment of the emerging regulatory landscape; drive cross-functional implementation of existing/new requirements across GRACS for devices and digital health solutions.
- Partner with Global Regulatory Teams to provide a broad GRACS perspective; share leading practices for regulatory strategies.
- Contribute to digital health strategic vision and planning; develop processes/systems to incorporate device/digital health into ways of working.
- Build/maintain processes, facilitate cross-functional discussions (Research, Manufacturing, Commercial, IT, and external partners as needed).
- Conduct policy reviews, support risk management and audit/assessment activities.
- Develop best-practice guidance for digital health regulatory deliverables.
- Independently manage lower-to-moderate complexity initiatives (track milestones/risks/issues/dependencies; escalate with solutions).
- Perform independent research/fact-finding to identify gaps and support regulatory/operational decisions.
- Communicate effectively in written/verbal formats; demonstrate ownership and influence without authority.
Education:
- Minimum: Bachelorβs degree in Regulatory Affairs, QA, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science.
- Preferred: Advanced degree and/or RAPS RAC, ASQ Quality, or Scrum certifications.
Required Qualifications/Skills:
- Knowledge of global regulatory requirements for drugs/devices; emerging regulatory landscape.
- Broad awareness of digital health technologies and application to drug development/biopharma products.
- Strong independent execution; analytical thinking and actionable recommendations.
- Cross-functional collaboration; excellent communication/presentation.
- Ability to work in ambiguity; manage priorities; ownership/accountability/initiative; curiosity.
- 2+ years relevant experience in medical device/biological/pharmaceutical research or related compliance/manufacturing/testing/quality/regulatory roles.
Preferred Skills:
- (Not specified.)
Compensation/Benefits:
- Salary range: $117,000.00 - $184,200.00; eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits incl. medical/dental/vision, retirement (401(k)), paid holidays/vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.