Hiring: Director GRA Digital Health and Device Company: EMD Serono, Inc. Location: Billerica, MA Job Posted Time: 2026-09-10 11:46:26 Target Skills & Keywords : GCP About the job Experience: •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. •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. Required Skills: •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. •Shape submission dossiers, lead agency interactions, and translate complex regulatory landscapes into actionable strategies that accelerate development timelines. •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. 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. •Demonstrated success in 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. •Demonstrated capacity 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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!