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 role coordinates recall and field action activity from health hazard evaluation through strategy development, regulatory and customer notifications, effectiveness checks, and closure. It also performs complaint reportability assessments and adverse event evaluations and filings, maintains recall readiness and process metrics, supports audits and inspections, and identifies compliance risks and improvement opportunities. Travel is required as business needs dictate.

Requirements

Minimum 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 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 Part 806, 21 CFR Part 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.
Demonstrated ability to lead time-sensitive cross-functional activity and make sound decisions under regulatory timelines.
Strong analytical and project management skills, organizational skills, attention to detail, communication skills, and systematic problem-solving skills.
Ability to multitask and communicate and influence effectively across functions.
Strong computer skills, including MS Word, MS Excel (charts and pivot tables), PowerPoint, database management, and statistical analysis.
Bachelor’s degree or equivalent experience in Engineering, Science, Nursing, a related scientific discipline, or equivalent.

Nice To Haves

Clinical experience.
Experience with complaint handling systems.
Experience with adverse event reporting, such as MDR and vigilance, and health hazard or risk evaluation.
Experience owning or authoring QMS procedures and supporting internal, external, and MDSAP audits.

Responsibilities

Own the end-to-end recall and field action process, including coordinating health hazard evaluations with Risk Management, developing regional strategies, completing regulatory, customer, and distributor notifications, conducting effectiveness checks, and closing actions.
Serve as the primary point of contact for recalls, field safety corrective actions, and advisory notices; coordinate with regional regulatory partners and distributors to ensure global notifications are on time.
Maintain recall readiness through 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; keep them 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 timelines for the United States, Canada, the EU, and other regions.
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 investigations and timely corrective actions, escalating issues to senior management as needed.
Support internal and external audits and inspections, including MDSAP, for recall, adverse event, and post-market surveillance activities, and facilitate closure of findings.
Identify compliance risks and process improvement opportunities and escalate when necessary.
Uphold AirLife’s values, contribute to a positive team environment, follow company policies and guidelines, and perform work accurately and efficiently.

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 applicable eligibility requirements.