Solustaff is recruiting a Compliance Product Manager for their client, a multi-national medical device company. This position will optimally be based in either Atlanta, Washington, DC or the Bay Area. The position requires working across multiple business areas, knowledge of software and hardware in medical devices and the ability to work within a global organization. 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.
Responsibilities
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 standardsCollaborate with cross-functional teams to define compliance strategies that align with product development goals, ensuring timely and successful market accessIdentify and translate regulatory requirements into actionable product specifications, working closely with engineering, quality, and clinical teamsConduct risk assessments to identify potential compliance issues and proactively implement mitigation strategies to ensure patient safety and product integrityCollaborate with R&D, quality assurance, legal, and marketing teams to integrate compliance considerations into product development and marketing strategiesMonitor post-market activities, including adverse events and recalls, and implement corrective actions as necessary to maintain compliance and product performanceAct as a liaison with regulatory agencies, notified bodies, and other relevant authorities to facilitate communication and ensure adherence to regulations
Requirements
Requirements
Bachelor’s Degree; Advanced degree preferred5 years compliance backgroundExtensive knowledge of healthcare regulations like ROCR/MIPS/HIPAAStrong presentation and communication skillsGood overall knowledge of the inner workings of major healthcare systems around the globeAbility to work effectively in a fast-paced, evolving environment and manage multiple projects simultaneously
Benefits
401K match, PTO, medical/dental/vision, tuition reimbursement