POSITION SUMMARYThe 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.
POSITION QUALIFICATIONSKnowledge, Skills, & Abilities: - 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.
Level of Experience: - 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.
Level of Education: - A bachelor's degree or equivalent experience in Engineering, Science, Nursing, related scientific discipline, or equivalent.
Travel: As the business needs.
ESSENTIAL DUTIES AND RESPONSIBILITIES- Own the recall and field action process end to end, including health hazard evaluation coordination with Risk Management, leading strategy development by region, completion of regulatory notification, customer and distributor notification, effectiveness checks and closure.
- Serve as the primary point of contact for recalls, field safety corrective actions and advisory notices, and coordinate with regional regulatory partners and distributors to ensure on-time notification globally.
- Maintain recall readiness, including regulatory notification matrices by country, templates, lessons learned, and training.
- Act as process owner for QMS procedures, work instructions and forms covering recalls/field actions/field safety notices and their applicable reporting, ensuring they are current, effective and aligned with applicable regulations.
- Maintain metrics for the recall and field action process
- Perform reportability assessments of complaints and adverse events and complete MDR and vigilance evaluations and filings in compliance with regulations and timelines for the United States, Canada, the EU (EU MDR) and other regions as applicable.
- Maintain effective relationships with global regulatory authorities and respond to field action and complaint-related inquiries within established timelines.
- Work with manufacturing sites and Quality Engineering to ensure 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 PMS activities and facilitate closure of findings.
- Identify compliance risks and process improvement opportunities and escalate when necessary.
OTHER RESPONSIBILITIES- Uphold and embody AirLife's values in all aspects of work.
- Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
- Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
- Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
- Contribute to building and maintaining a positive team environment.
- Assure all policies and guidelines are implemented and followed.
BENEFITSAirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.
Please note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.
