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Medical Device Complaint Specialist Aviso, LLC - 3.8 Fremont, CA Job Details Full-time $50.00 - $53.85 an hour 22 hours ago Benefits Work from home Qualifications Incident investigation techniques for hazard identification Incident reporting compliance Quality records maintenance Defect resolution root cause analysis Supplier corrective action implementation Adverse event reporting Technical documentation ISO standards 5 years Preventive action implementation Engineering Reliability analysis Quality control preventive actions Corrective and preventive actions (CAPA) Post-sales issue resolution Trend analysis Data summary reports System maintenance Collaboration with product development teams Bachelor's degree in engineering Quality risk management Continuous improvement Regulatory readiness in healthcare Biomedical regulatory compliance Regulatory submissions Safety records management Senior level Surveillance data analysis Quality control records management Product quality failure

Full 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.