Symmetrio is recruiting for an EHR Software Product Manager (Electronic Health Records), for our client, a multi-national medical device company. This position will optimally be based in either Atlanta, Washington, DC or the San Francisco Bay Area, though uniquely qualified candidates in the US will be considered. The position requires working across multiple business areas, with primary responsibility for defining software product requirements that meet regulatory and compliance requirements and requires knowledge and experience with software and hardware integration in medical devices. The role also requires the ability to work within a global organization and have working knowledge of international regulatory and compliance standards. Travel will be approximately 25%, both domestic and international. The company provides excellent benefits, including medical/dental/vision, matching 401K and a generous PTO policy.
- Define regulatory product requirements working with health policy and government affairs team
- Manage product certification as needed for active participation in the ONC Health IT Certification Program
- Lead development of compliance specific content for marketing and digital assets
- Serve as the primary point of contact for all compliance-related matters, staying up-to-date with global medical device regulations, including FDA, EU MDR, and ISO standards.
- Collaborate with cross-functional teams to define compliance strategies that align with product development goals, ensuring timely and successful market access.
- Identify and translate regulatory requirements into actionable product specifications, working closely with engineering, quality, and clinical teams.
- Conduct risk assessments to identify potential compliance issues and proactively implement mitigation strategies to ensure patient safety and product integrity.
- Ensure all cybersecurity best practice guidelines are followed and translate product security vulnerability risks, through threat modeling and pen tests, to develop remediation and feature enhancements/specifications to mitigate threats
- Communicate changing government regulations and compliance requirements to sales and customer support
- Collaborate with R&D, quality assurance, legal, and marketing teams to integrate compliance considerations into product development and marketing strategies.
- Bachelor’s Degree; Advanced degree preferred.
- 5 years EHR software product management
- 5 years medical device software integration experience a plus
- Demonstrated experience translating technical specifications into marketing/sales assets
- Extensive knowledge of healthcare regulations like ROCR/MIPS/HIPAA, 21st Century Cures Act.
- Strong presentation and communication skills.
- Good overall knowledge of the inner workings of major healthcare systems around the globe.
- Ability to work effectively in a fast-paced, evolving environment and manage multiple projects simultaneously.