Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-RCH Digital Health & Devices
Recruiter: Shelby Elizabeth Briggs
This information is for internals only. Please do not share outside of the organization.Your RoleDigital health technologies and connected medical devices are reshaping how medicines reach and benefit patients - and this role sits at the very center of that transformation. As Director, Regulatory Affairs for Digital Health and Medical Devices, you will serve as the global regulatory lead for an innovative portfolio of digital health technologies (DHTs) and medical devices that support the medicinal product pipeline. Working with high autonomy and recognized expertise, you will define and execute regulatory strategies that enable the development and approval of Software as a Medical Device (SaMD), digital biomarkers, and combination products across major global markets.
In this pivotal role, you will author and oversee 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. You will shape submission dossiers, lead agency interactions, and translate complex regulatory landscapes into actionable strategies that accelerate development timelines. Your expertise will directly influence how the organization navigates the evolving intersection of digital innovation and regulatory science, making you a critical voice in cross-functional governance and a trusted advisor to senior leadership.
You will collaborate closely with Device Engineering, Device Quality, and Commercial teams, representing the regulatory function in global project teams and contributing to the continuous evolution of regulatory knowledge and best practices across the organization. This is a rare opportunity to operate at the forefront of a rapidly evolving regulatory discipline, with global reach and meaningful impact on patient outcomes.
Who You Are:Minimum Qualifications:- Master's degree or equivalent experience in Life Sciences or a related discipline
- Minimum 10 or more years of regulatory affairs experience, with 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, with the ability to represent the organization confidently in agency meetings.
- Fluency in English (written and spoken) is required.
Preferred Qualifications:- 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.
Location: Billerica, MA, USA
Travel:
Pay range for this position: $183,400.00 - $275,000.00
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
