Sr. Scientist, Regulatory Liaison

Job Description

Team Overview:

The GRACS RDDH team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world through a highly regulated industry.

Position Overview:

Under the direction and guidance of the 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: Bachelor’s 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.
• Demon