Senior Post-Market Surveillance Analyst

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🔥 0 minutes ago

🚗 Michigan – Remote

🚗 Michigan – Remote

⏰ Full Time

🟠 Senior

🧐 Analyst

👻 Ghost score 10%

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AirLife

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1981

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

AirLife is the global leader in consumable breathing products, specializing in respiratory care, anesthesia, and patient monitoring solutions. AirLife has brought together the most trusted brands in anesthesia and respiratory care, such as SunMed, Salter Labs, Ventlab, Ethox Medical, Westmed, Vital Signs, and Ballard. Their product portfolio spans the continuum of care from first responder to home care, focusing on safety, patient comfort, and clinical performance.

📋 Description

• 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

• 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

• 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

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