This is an hybrid position requiring the team member to be onsite 3 days a week.Job Summary- The Manager, Regulatory Affairs Digital Health & Innovation provides strategic regulatory leadership for software-enabled medical devices, including Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and other emerging digital health solutions.
- This role serves as a regulatory subject matter expert for digital health product development and lifecycle management, with a strong focus on software-driven medical technologies, cybersecurity requirements, and regulatory strategy for digital health innovations.
- The Manager will partner closely with R&D, Digital & Technology, Quality, Product Management, and other cross-functional stakeholders to define regulatory pathways, interpret evolving requirements, support compliant product development, and enable timely regulatory submissions and lifecycle changes.
- In addition, this role will play a key role in advancing Regulatory Affairs digital transformation by identifying, shaping, and supporting the adoption of compliant AI-enabled tools, automation solutions, and RA-focused digital capabilities that improve productivity, scalability, data traceability, submission quality, and operational efficiency across Regulatory Affairs.
Essential Duties and Responsibilities- Lead the development and execution of regulatory strategies for software-enabled medical devices across the product lifecycle, including early product development, design changes, regulatory submissions, health authority interactions, and post-market lifecycle activities.
- Partner with R&D, Digital & Technology, Quality, Product Management, and other subject matter experts to provide regulatory guidance and ensure applicable requirements are appropriately incorporated into software-enabled medical device design, development, risk management, usability, verification and validation, cybersecurity documentation, change management, and lifecycle management processes.
- Support the expansion of internal Regulatory Affairs capabilities in digital health by developing and maintaining regulatory knowledge, best practices, templates, assessment tools, and internal guidance related to software, cybersecurity, AI-enabled technologies, and emerging digital health expectations.
- Provide regulatory support for cybersecurity considerations across the digital health portfolio, including assessment of documentation needs, review of cybersecurity-related content, interpretation of regulatory expectations, and support for post-market cybersecurity considerations, as applicable.
- Author, review, and support regulatory submission content and health authority responses related to software functionality, software architecture, software development processes, cybersecurity, risk management, verification and validation, and hardware/software integration.
- Conduct regulatory assessments for software-related product changes, cybersecurity updates, AI-related considerations, and other digital health lifecycle changes to determine regulatory impact and submission requirements.
- Support Regulatory Affairs digital transformation by serving as a functional subject matter expert for AI and digital enablement, including identifying and evaluating AI-enabled solutions, defining compliance-critical use cases, supporting implementation planning, and ensuring regulatory workflows, submissions, document automation, and data traceability are aligned with regulatory, quality, and business needs.
- Lead or coordinate cross-functional regulatory initiatives by defining scope, milestones, roles and responsibilities, risks, dependencies, and deliverables to support consistent and timely execution.
- Maintain awareness of applicable U.S., European, and rest-of-world regulatory requirements, standards, guidance, competent authority expectations, and industry best practices relevant to medical devices, software-enabled products, cybersecurity, and AI-enabled technologies.
- Other duties as assigned
Education- Bachelor's degree in Life Sciences, Biomedical Engineering, Software Engineering, Computer Science, Data Science, Artificial Intelligence, Machine Learning, Health Informatics, Regulatory Affairs, or another related technical, scientific, healthcare, or engineering field or equivalent experience
Work Experience- Bachelor's degree with minimum 8 years, or Master's/PhD with minimum 3 years of experience supporting medical devices, software-enabled products, digital health technologies, or other regulated healthcare technologies.
- Working knowledge of regulations, standards, and guidance applicable to software and cybersecurity in medical devices, such as IEC 62304, IEC 82304, ISO 14971, FDA cybersecurity expectations, FDA software guidance, EU MDR requirements, and related global expectations
- Experience assessing technical and regulatory issues related to software development, software changes, cybersecurity, risk management, verification and validation.
- Working knowledge of cybersecurity expectations for software-enabled medical devices, including cybersecurity risk management, security-related documentation, vulnerability considerations, software bill of materials concepts, and applicable regulatory expectations.
- Experience evaluating, supporting, or implementing AI-enabled tools, automation, or digital solutions in a regulated or quality-controlled environment.
Preferred Knowledge, Skills and Abilities- Hands-on experience supporting regulatory strategy or submissions for software-based medical devices, including SiMD, SaMD, embedded firmware, connected systems, or hardware/software integrated products.
- Experience with AI/ML-enabled medical devices, digital therapeutics, connected health systems, clinical decision support software, or AI-enabled regulatory process improvement.
- Demonstrated ability to partner effectively with Digital & Technology, R&D, Quality, Product Management, Clinical, and Commercial teams to shape regulatory strategy, support health authority interactions, and drive lifecycle compliance
- In-depth knowledge of U.S. FDA regulations, including applicable requirements under Title 21 CFR, and EU Medical Device Regulation MDR 2017/745, with practical experience applying requirements during development and post-market activities.
- Strong project management skills, including experience developing project plans, managing timelines, identifying risks, coordinating cross-functional deliverables, and communicating status to leadership.
- Experience developing regulatory procedures, templates, work instructions, training materials, or internal capability-building programs.
- Regulatory Affairs Certification, such as RAC, or advanced degree preferred.
Additional Requirements- Demonstrated ability to lead or contribute to cross-functional initiatives in a matrixed organization, with the ability to influence stakeholders and drive alignment across technical, quality, regulatory, and business functions.
- Strong analytical, problem-solving, and critical-thinking skills, with the ability to assess complex technical and regulatory issues and provide balanced, risk-based recommendations.
- Strong communication skills, including the ability to translate complex technical and regulatory concepts into clear, practical guidance for diverse audiences.
- Self-motivated, proactive, and comfortable working independently in a fast-paced and evolving environment.
License and Certifications- Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred
Travel Requirements10%: Up to 26 business days per year
Physical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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