Remote Global Post-Market Surveillance Lead for Med Devices

United States Digital Space LLC; United States; Remote; USD 130,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Equity program

Job summary

Hilo by Aktiia seeks a Post-Market Surveillance Manager to build and run a global PMS system, owning complaint handling, adverse-event reporting, and data governance across Customer Support, QA, Regulatory, Engineering, Clinical, and Product. This is a hands-on role driving product safety and customer experience.

You will translate PMS insights into action, lead multi-market reporting, and support regulatory submissions while acting as SME during audits and inspections.

Qualifications

• 7+ years in medical-device post-market surveillance or regulatory affairs.
• Bachelor's degree required.
• Experience with FDA MDR and EU MDR PMS.
• Strong data analysis to derive risk-based recommendations.
• Cross-functional leadership and stakeholder influence.

Responsibilities

• Design and operate global post-market surveillance system.
• Oversee complaint handling and adverse-event reporting.
• Develop KPIs, dashboards, and trend analyses.
• Lead cross-functional rollout across departments.
• Present performance to leadership and support PMS reports.
• Serve as SME during audits and inspections.

Skills

Post-market surveillance

Regulatory affairs

Regulatory submissions

Data analysis

Stakeholder influence

Education

Bachelor's degree

Job description

Hilo by Aktiia seeks a Post-Market Surveillance Manager to build and run a global PMS system, owning complaint handling, adverse-event reporting, and data governance across Customer Support, QA, Regulatory, Engineering, Clinical, and Product. This is a hands-on role driving product safety and customer experience.

You will translate PMS insights into action, lead multi-market reporting, and support regulatory submissions while acting as SME during audits and inspections.