Senior Post-Market Surveillance Analyst

AirLife

. Lead the recall and field action process end to end .

Posted 10/31/2026full-timeRemote • Michigan • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing recalls and field actions within medical device quality systems, ensuring compliance with regulatory standards such as ISO 13485 and FDA QSR. Possesses strong analytical, project management, and communication skills to effectively coordinate cross-functional activities and maintain relationships with regulatory authorities.

Highest-signal resume keywords

Recall ManagementRegulatory ComplianceQuality Management System (QMS)Adverse Event ReportingProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ISO 13485FDA QSRMDR ReportingStatistical AnalysisDatabase ManagementComplaint HandlingField Safety Corrective ActionHealth Hazard EvaluationVigilance ReportingQuality System Experience

Soft Skills

Analytical SkillsOrganizational SkillsCommunication SkillsProblem-Solving SkillsMultitasking

Tools & Technologies

MS WordMS ExcelPowerPoint

Industry Keywords

Medical Device RegulationsMDSAP AuditAdvisory NoticeCross-Functional CollaborationRegulatory Authorities

About the role

Key responsibilities & impact

Lead the recall and field action process end to end
Coordinate health hazard evaluations with Risk Management
Develop recall and field-action strategies by region
Complete regulatory, customer, and distributor notifications
Conduct effectiveness checks and close recall and field-action activities
Serve as the primary contact for recalls, field safety corrective actions, and advisory notices
Coordinate with regional regulatory partners and distributors to ensure timely global notification
Maintain recall readiness, including country regulatory notification matrices, templates, lessons learned, and training
Own QMS procedures, work instructions, and forms covering recalls, field actions, field safety notices, and applicable reporting
Maintain recall and field-action process metrics
Perform complaint and adverse-event reportability assessments
Complete MDR and vigilance evaluations and filings for the United States, Canada, the EU, and other applicable regions
Maintain relationships with global regulatory authorities and respond to field-action and complaint-related inquiries
Work with manufacturing sites and Quality Engineering on investigations and corrective actions
Escalate issues to senior management as needed
Support internal and external audits and inspections, including MDSAP, and facilitate closure of findings
Identify compliance risks and process-improvement opportunities
Uphold AirLife’s values, quality and safety standards, policies, and guidelines
Contribute to a positive team environment and use company resources efficiently

Requirements

What you’ll need

Knowledge of medical-device quality standards, including ISO 13485, FDA QSR, EU Medical Device Directives and Regulations, Australian TGA, Japanese PMDA, Brazilian ANVISA, and Canadian Medical Device Regulations
Working knowledge of recall, field safety corrective action, advisory notice, adverse event, and vigilance reporting requirements
Familiarity with the MDSAP audit model and expectations
Strong analytical and project management skills
Ability to lead time-sensitive, cross-functional activities and make sound decisions under regulatory timelines
Excellent verbal and written communication and analytical skills
Excellent organizational skills and attention to detail
Ability to multitask
Systematic problem-solving skills
Strong computer skills, including MS Word, MS Excel with charts and pivot tables, PowerPoint, database management, and statistical analysis
Ability to work and influence cross-functionally
Minimum 7–10 years of Quality System experience in an FDA-regulated and/or ISO-certified facility, preferably ISO 13485
Direct experience leading or managing product recalls, field corrective actions, or advisory notices
Clinical experience preferred
Experience with complaint-handling systems
Experience with adverse event reporting, including MDR and vigilance, and health hazard or risk evaluation
Experience owning or authoring QMS procedures and supporting internal, external, and MDSAP audits preferred
Bachelor’s degree or equivalent experience in Engineering, Science, Nursing, a related scientific discipline, or equivalent
Travel as business needs require

Benefits

Comp & perks

Medical coverage
Dental coverage
Vision coverage
401(k)
Paid time off
Paid holidays
Bereavement leave
Employee Assistance Program resources
Medical leave benefits
Bonus, commission, or other incentive compensation may be available for certain positions
Travel as business needs require