Medical Device Complaint Specialist

Aviso, LLC; Fremont (CA); Hybrid; USD 95,000 - 129,000; Full time

Benefits offered by this job

Flexible work from home options

Job summary

Aviso, LLC is seeking a Senior Post-Market Surveillance Specialist to oversee the PMS system for surgical robotic products. You will independently manage the end-to-end complaint lifecycle from intake through risk assessment and global reporting, ensuring compliance with regulatory and QMS standards.

In this hybrid role, you will collaborate with Medical Affairs, Customer Service, Global Sales, and Clinical Specialists to gather complete event data and drive CAPAs when needed.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 5+ years of direct experience handling medical device complaints and/or post-market surveillance in a regulated medical device environment.
• Hybrid work arrangement as required by business needs.

Responsibilities

• Maintain and enhance the PMS system in compliance with regulatory and QMS standards.
• Execute complaint intake, root-cause investigation, reportability assessments, and timely file closures.
• Evaluate complaint records for accuracy and thoroughness; ensure audit-ready files.
• Collaborate cross-functionally to obtain complete event data.
• Submit timely adverse event reports to global regulatory bodies per timelines.
• Perform PMS data trend analysis and present findings to leadership.

Skills

Experience

Education

Bachelor’s degree

Job description

Target Compensation: ~$112,000 / year ($53.85 / hour equivalent)

Work Location: Hybrid

Position Summary:

The Senior Post-Market Surveillance Specialist oversees the maintenance and continuous improvement of the Post-Market Surveillance (PMS) system for surgical robotic products. This position independently manages the end-to-end complaint lifecycle—from initial intake, investigation, and risk assessment through mandatory domestic and international adverse event reporting and complaint closure.

Essential Duties & Responsibilities:

• Maintain and enhance the Post-Market Surveillance (PMS) system in compliance with regulatory and Quality Management System (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.
• Conduct Good Faith Efforts to retrieve return products and gather required details for safety and functional evaluations.
• 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 (e.g., US FDA 21 CFR 803, EU MDR/MDD, Health Canada, PMDA, NMPA) 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 (e.g., FMEA) when new failure modes or frequency increases are identified.
• Initiate and support Corrective and Preventive Actions (CAPA) and Supplier Corrective Action Requests (SCAR) driven by PMS findings.
• Draft and maintain PMS documentation, including PMS Plans, PMS Reports (PMS-R), and Periodic Safety Update Reports (PSUR).
• Support internal and external regulatory audits, inspections, and customer inquiries regarding failure analysis results.
• Maintain compliance with company QMS standards and Environmental Health and Safety (EHS) policies.

Minimum Required Qualifications:

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

Preferred Qualifications & Skills:

• Regulatory Knowledge: Direct working knowledge of US FDA 21 CFR 803 (MDR), FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD vigilance reporting, and international regulatory requirements.
• Professional Capabilities: Proven ability to manage multiple regulatory projects independently, prioritize deliverables effectively, and collaborate smoothly across cross-functional teams.

Flexible work from home options available.