[Hiring] Senior Post-Market Surveillance Analyst @AirLife

Role Description

The Sr. Post-Market Surveillance Analyst leads the recall and field action process and serves as a primary resource for adverse event reporting, ensuring timely and compliant vigilance and advisory notice activity under FDA, ISO 13485, MDSAP and other applicable global requirements. This role owns the associated Quality Management System procedures, mentors team members, and builds cross-functional bench strength in recall and field action execution.

Qualifications

• Knowledge of quality standards for medical devices (e.g., ISO 13485, FDA QSR, EU Medical Device Directives and Regulations, Australian TGA, Japanese PMDA, Brazilian ANVISA and Canadian Medical Device Regulations).
• Strong analytical and project management skills.
• Working knowledge of recall, field safety corrective action and advisory notice requirements (e.g., 21 CFR Part 806, 21 CFR Part 7, EU MDR vigilance and field safety corrective action requirements, and applicable TGA, Health Canada, PMDA and ANVISA requirements).
• Working knowledge of adverse event and vigilance reporting requirements (e.g., 21 CFR Part 803, EU MDR, Canadian Medical Device Regulations and other applicable regional requirements).
• Familiarity with 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.
• Excellent verbal and written communication and analytical skills.
• Excellent organizational skills and attention to detail.
• Ability to multi-task.
• Sound, systematic problem-solving skills.
• Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, database management and statistical analysis.
• Effective communication skills, with an ability to work and influence cross-functionally.

Requirements

• 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 product recalls, field corrective actions or advisory notices.
• Clinical experience preferred.
• Experience with complaint handling systems.
• Experience with adverse event reporting (e.g., MDR and vigilance) and health hazard or risk evaluation.
• Experience owning or authoring QMS procedures and supporting internal, external and MDSAP audits preferred.
• A bachelor’s degree or equivalent experience in Engineering, Science, Nursing, related scientific discipline, or equivalent.
• As the business needs.

Benefits

• Comprehensive benefits package, including medical, dental, and vision coverage.
• 401(k).
• Paid time off.
• Paid holidays.
• Bereavement leave.
• Employee Assistance Program resources.
• Medical leave benefits, subject to applicable eligibility requirements.
• Certain positions may also be eligible for bonus, commission, or other incentive compensation.