Director GRA Digital Health and Device

Merck•Billerica, MA

1d•Onsite

About The Position

Digital health technologies and connected medical devices are reshaping how medicines reach and benefit patients. This role serves as the global regulatory lead for an innovative portfolio of digital health technologies (DHTs) and medical devices that support the medicinal product pipeline. The position defines and executes regulatory strategies for the development and approval of Software as a Medical Device (SaMD), digital biomarkers, and combination products across major global markets. The role involves authoring and overseeing health authority submissions worldwide, including interactions with the FDA, EMA, and other regulatory bodies, while serving as the primary device regulatory lead within global regulatory strategy teams. Responsibilities include shaping submission dossiers, leading agency interactions, and translating complex regulatory landscapes into actionable strategies to accelerate development timelines. The role influences how the organization navigates the intersection of digital innovation and regulatory science, acting as a critical voice in cross-functional governance and a trusted advisor to senior leadership. Collaboration with Device Engineering, Device Quality, and Commercial teams is expected, representing the regulatory function in global project teams and contributing to the evolution of regulatory knowledge and best practices. This is an opportunity to operate at the forefront of a rapidly evolving regulatory discipline with global reach and impact on patient outcomes.

Requirements

Master’s degree or equivalent experience in Life Sciences or a related discipline.
Minimum 10 or more years of regulatory affairs experience.
At least 5 years of recent, hands-on experience in digital health technologies in drug development, Software as a Medical Device, and digital biomarkers in drug development.
Demonstrated practical experience in device regulatory affairs, including IDE, 510(k), or PMA filings, CE marking under EU-MDR, the eSTAR process, software validation, human factors, and design verification and validation.
Solid knowledge of clinical development processes, trial design, ICH guidelines, Good Clinical Practice (GCP), ISO 14155, EU-MDR, and relevant medical device guidance documents.
Proven track record of direct, credible interactions with regulatory authorities, including the FDA and EMA.
Ability to represent the organization confidently in agency meetings.
Fluency in English (written and spoken).

Nice To Haves

Experience with MDSAP and ISO 13485 quality management system requirements in a regulated device development environment.
Ability to work effectively in a global, matrixed organization, building trust and credibility across diverse cross-functional teams and external stakeholders.
Strong communication skills with the ability to convey complex regulatory concepts clearly to technical and non-technical audiences, including senior leadership.

Responsibilities

Serve as the global regulatory lead for an innovative portfolio of digital health technologies (DHTs) and medical devices.
Define and execute regulatory strategies for Software as a Medical Device (SaMD), digital biomarkers, and combination products.
Author and oversee health authority submissions worldwide.
Lead agency interactions with regulatory bodies such as the FDA and EMA.
Shape submission dossiers and translate complex regulatory landscapes into actionable strategies.
Represent the regulatory function in global project teams.
Collaborate closely with Device Engineering, Device Quality, and Commercial teams.