Senior Manager, Product Safety Risk Management – Medical Device

This is a fully remote position, open to applicants in Mississippi.

📋 Description

• Responsible for the product safety risk management framework and governance structure.

• Establishes, executes, and continuously enhances policies, procedures, templates, tools, and quality system controls.

• Directs the safety risk strategy for the medical imaging portfolio and intricate programs.

• Ensures the integration of product safety risk management with design controls.

• Monitors the quality and thoroughness of risk management files and associated documentation.

• Oversees post-market safety initiatives.

• Contributes to product safety risk management content for regulatory filings.

• Acts as the primary leader in product safety risk management for audits, inspections, and regulatory engagements.

• Enhances organizational capability by leading and nurturing talent.

• Fosters a culture centered on patient safety, accountability, and continuous improvement.

⛳️ Requirements

• 8–10 years of progressive experience in the medical device or healthcare technology sector.

• Proven expertise in applying ISO 14971 to software-driven medical devices during both pre-market and post-market stages.

• Solid understanding of design controls and their connection to usability engineering, cybersecurity risk management, software development lifecycles, and post-market surveillance.

• Demonstrated capability to influence senior stakeholders, facilitate cross-functional decision-making, and articulate complex risk issues with clarity and discretion.

• Proven experience in leading, managing, or developing professionals in safety risk management or closely related quality and regulatory roles.

• Advanced knowledge of relevant standards and regulations, including ISO 13485, IEC 62304, IEC 62366-1, 21 CFR Part 820, the Canada Medical Devices Regulations, and EU MDR 2017/745.

• Experience in supporting Software as a Medical Device and contemporary software development environments, including agile methodologies and cloud-based solutions.

• Relevant advanced training or certification in medical device risk management, quality systems, or regulatory affairs.

• Familiarity with enabling technologies and work management platforms such as Jira, Aha!, Xray Test Management, and Microsoft 365 is preferred.

🏝️ Benefits

• Remote-first / work from home culture.

• Flexible vacation policy to help you rest, recharge, and connect with family and friends.

• Paid leave benefits.

• Comprehensive health, dental, and vision insurance.

• 401k retirement savings plan.

• Infertility benefits.

• Tuition reimbursement, life insurance, EAP – and more!