Sr. Post-Market Surveillance Analyst

AirLife•Grand Rapids, MI

About The Position

The Sr. Post-Market Surveillance Analyst leads AirLife’s recall and field action process and serves as a primary resource for adverse event reporting. The role ensures timely, compliant vigilance and advisory notice activity under FDA, ISO 13485, MDSAP, and other applicable global requirements. It owns related Quality Management System procedures, mentors team members, and builds cross-functional capability in recall and field action execution. The position coordinates health hazard evaluations with Risk Management; develops regional strategies; manages regulatory, customer, and distributor notifications; and oversees effectiveness checks and closure. It also performs complaint and adverse-event reportability assessments, completes MDR and vigilance evaluations and filings, maintains recall readiness and process metrics, and supports audits, inspections, investigations, corrective actions, and continual improvement. The role requires a minimum of 7–10 years of Quality System experience in an FDA-regulated and/or ISO-certified facility, preferably ISO 13485, including direct experience leading or managing recalls, field corrective actions, or advisory notices. A bachelor’s degree or equivalent experience in Engineering, Science, Nursing, a related scientific discipline, or equivalent is required. Travel is as business needs require.

Requirements

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.
Knowledge of medical-device quality standards and regulations, 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, and advisory notice requirements, including 21 CFR Parts 806 and 7, EU MDR requirements, and applicable TGA, Health Canada, PMDA, and ANVISA requirements.
Working knowledge of adverse-event and vigilance reporting requirements, including 21 CFR Part 803, EU MDR, Canadian Medical Device Regulations, and other applicable regional requirements.
Familiarity with the MDSAP audit model and expectations for advisory notices, adverse-event reporting, and complaint handling.
Experience with complaint-handling systems.
Experience with adverse-event reporting, such as MDR and vigilance, and health hazard or risk evaluation.
Bachelor’s degree or equivalent experience in Engineering, Science, Nursing, a related scientific discipline, or equivalent.
Strong analytical, project management, organizational, and systematic problem-solving skills; attention to detail and ability to multitask.
Demonstrated ability to lead time-sensitive cross-functional activity and make sound decisions under regulatory timelines.
Excellent verbal and written communication skills and ability to work with and influence cross-functional partners.
Strong computer skills, including MS Word, MS Excel (charts and pivot tables), PowerPoint, database management, and statistical analysis.
Travel as business needs require.

Nice To Haves

Clinical experience.
Experience owning or authoring QMS procedures and supporting internal, external, and MDSAP audits.

Responsibilities

Own the recall and field action process end to end, including coordinating health hazard evaluations with Risk Management, leading regional strategy development, completing regulatory notifications, notifying customers and distributors, conducting effectiveness checks, and closing actions.
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 notifications.
Maintain recall readiness, including country-specific 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; ensure they remain current, effective, and aligned with regulations.
Maintain metrics for the recall and field action process.
Assess complaint and adverse-event reportability and complete MDR and vigilance evaluations and filings within applicable regulatory timelines for the United States, Canada, the EU, and other regions as applicable.
Maintain relationships with global regulatory authorities and respond to field action- and complaint-related inquiries within established timelines.
Work with manufacturing sites and Quality Engineering on thorough investigations and timely corrective actions, escalating to senior management as needed.
Support internal and external audits and inspections, including MDSAP, for recall, adverse-event, and post-market surveillance activities; facilitate closure of findings.
Identify compliance risks and process improvement opportunities and escalate when necessary.
Uphold AirLife’s values; demonstrate accuracy and thoroughness; promote quality and safety; treat people with respect and dignity; use time and company resources efficiently; contribute to a positive team environment; and follow company policies and guidelines.

Benefits

Medical coverage
Dental coverage
Vision coverage
401(k)
Paid time off
Paid holidays
Bereavement leave
Employee Assistance Program resources
Medical leave benefits
Certain positions may be eligible for bonus, commission, or other incentive compensation, subject to eligibility requirements.