Senior Post-Market Surveillance Specialist (Hybrid)

Aviso, LLC; Fremont (CA); Hybrid; USD 101,000 - 123,000; Full time

Benefits offered by this job

Flexible work from home

Job summary

Aviso, LLC is seeking a Senior Post-Market Surveillance Specialist to own the end-to-end PMS for surgical robotic products in a hybrid work setting. You will manage intake, investigations, risk assessment, and timely regulatory reporting to the US FDA and international bodies, ensuring audit-ready PMS documentation and CAPA alignment.

Ideal candidates bring 5+ years in medical device complaints or PMS within regulated environments, strong cross-functional collaboration, and a solid regulatory

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline (or equivalent combination of formal education and relevant professional experience).
• 5+ years of direct experience handling medical device complaints and/or post-market surveillance in a regulated medical device environment.
• Ability to work in a hybrid capacity as required by business needs.

Responsibilities

• Maintain and enhance the Post-Market Surveillance (PMS) system in compliance with regulatory and QMS standards.
• Independently execute complaint intake, root-cause investigation/analysis, reportability assessments, and timely complaint file closures.
• Evaluate complaint records for accuracy and thoroughness, executing follow-up actions as necessary to ensure audit-ready files.
• Collaborate cross-functionally with Medical Affairs, Customer Service, Global Sales, Professional Educators, and Clinical Specialists to obtain complete event data.
• Determine adverse event reportability and submit timely reports to global regulatory bodies per mandated timelines.
• Perform trend analysis on PMS data, draw actionable conclusions, and present findings to leadership and during monthly complaint review meetings.
• Identify emerging product issues, failure modes, or complaint trends; initiate immediate remedial actions or risk mitigations as appropriate.
• Collaborate with Design Quality Engineering to update Risk Management files when new failure modes or frequency increases are identified.
• Initiate and support CAPA and SCAR driven by PMS findings.
• Draft and maintain PMS documentation, including PMS Plans, PMS Reports, and PSUR.
• Support internal and external regulatory audits, inspections, and customer inquiries regarding failure analysis results.

Skills

Regulatory knowledge

Cross-functional collaboration

Medical device experience

Education

Bachelor's degree in Engineering Life Sciences or related field

Job description

Aviso, LLC is seeking a Senior Post-Market Surveillance Specialist to own the end-to-end PMS for surgical robotic products in a hybrid work setting. You will manage intake, investigations, risk assessment, and timely regulatory reporting to the US FDA and international bodies, ensuring audit-ready PMS documentation and CAPA alignment.

Ideal candidates bring 5+ years in medical device complaints or PMS within regulated environments, strong cross-functional collaboration, and a solid regulatory