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Compliance Product Manager
Location:
US-DC-Washington
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Symmetrio, a SoluStaff Company, 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 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.
  • Collaborate with R&D, quality assurance, legal, and marketing teams to integrate compliance considerations into product development and marketing strategies.
  • Monitor post-market activities, including adverse events and recalls, and implement corrective actions as necessary to maintain compliance and product performance.
  • Act as a liaison with regulatory agencies, notified bodies, and other relevant authorities to facilitate communication and ensure adherence to regulations.


Requirements

Requirements

  • Bachelors Degree; Advanced degree preferred.
  • 5 years compliance background.
  • Extensive knowledge of healthcare regulations like ROCR/MIPS/HIPAA.
  • 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.

Benefits

401K match, PTO, medical/dental/vision, tuition reimbursement

SoluStaff

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