Job Description

Position Overview:

Under the direction and guidance ofthe Executive Director, Regulatory Digital Health the incumbent will assist in driving the overarching strategy for the Digital Health Medical Device Modality in partnership with the Global Regulatory Leads (GRLs), Chemistry, Manufacturing and Control (CMC) scientists, Pharmacovigilance (PV), Global Labeling (GL), and various other functions.

The incumbent will partner with these organizations and others to ensure the development and clinical aspects needed to support, plan, and/or execute regulatory strategies and filings.

The incumbent will help drive the development of new processes and establishment of internal guidance/policy that enables timely and accurate advice to Global Regulatory Teams and Product Development Teams to ensure adherence to evolving global regulations.

Primary duties/assignments:

• Support communication and assessment of the emerging regulatory landscape and drive cross-functional implementation of existing and new requirements across affected Global Regulatory Affairs and Clinical Safety (GRACS) functional areas for devices and digital health solutions.
• Provide support to assigned Global Regulatory Teams (GRTs) with a broad GRACS perspective on device and digital health aspects impacting product development and share leading practices for teams to incorporate into their regulatory strategies.
• Contribute to the strategic vision and planning of digital health initiatives that establish operational processes and systems to fully incorporate device and digital health into the company way of working across the broad product portfolio.
• Build and maintain new processes that facilitate resources and support key activities and initiatives.
• Ensure close collaboration with cross-functional and cross-divisional teams (Research, Manufacturing, Commercial, IT) to align and incorporate regulatory requirements into strategies for devices and digital health solutions to ensure successful product registrations.
• Conduct assigned policy reviews and support organizational risk management initiatives, including providing audit and assessment support.
• Support the development of best-practice guidance for regulatory deliverables for digital health to support therapeutically aligned development teams.
• Schedule as needed and actively facilitate discussions and interactions with cross-functional and cross-divisional teams and/or external partners.
• Independently manage assigned work or lower-to-moderate complexity initiatives, which includes to track milestones, risks, issues, and dependencies, and escalate effectively with recommended solutions.
• Conduct independent research, fact-finding, and guidance review to identify gaps, synthesize insights, and support regulatory or operational decisions.
• Communicate clearly in written and verbal formats and present effectively in team and cross-functional settings with minimal support.
• Demonstrate ownership, accountability, initiative, and sound judgment while working effectively in ambiguous or changing environments.
• Build productive working relationships across functions and influence without formal authority to move work forward.
• Support team capability by sharing knowledge, lessons learned, and best practices with colleagues as needed.

Education:

• Minimum:Bachelors Degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field
• Preferred:Advanced degree and/or RAPS RAC, ASQ Quality, or Scrum certifications

Required Experience and Skills:

• Knowledge of global regulatory requirements and the emerging landscape for drugs and devices for both new and existing products.
• Broad awareness of digital health technologies and their application to drug development and marketed biopharmaceutical products.
• Strong independent execution of assigned work and ability to deliver high-quality outputs with limited supervision.
• Demonstrated analytical thinking, problem solving, and ability to interpret information and translate it into actionable recommendations.
• Strong cross-functional collaboration skills and ability to influence without formal authority.
• Excellent communication and presentation skills.
• Ability to work effectively in ambiguity, manage competing priorities, and adapt to changing business needs.
• Demonstrated ownership, accountability, and initiative.
• Curiosity and willingness to learn, take on stretch assignments, and expand knowledge of policies, processes, and tools.
• At least two (2) years of relevant experience, including medical device/biological/pharmaceutical research; compliance, manufacturing, testing, quality, regulatory affairs; or related fields.
• Preferred fields of study include engineering, regulatory affairs, quality, policy, or related sciences.

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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