Senior Post-Market Surveillance Analyst

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Oversee the entire recall and field action process from start to finish

• Collaborate with Risk Management to conduct health hazard evaluations

• Create strategies for recalls and field actions tailored to specific regions

• Manage notifications for regulatory bodies, customers, and distributors

• Execute effectiveness checks and finalize recall and field action tasks

• Act as the main point of contact for recalls, field safety corrective actions, and advisory notices

• Work with regional regulatory partners and distributors to ensure prompt global notifications

• Ensure recall preparedness by maintaining regulatory notification matrices, templates, lessons learned, and training

• Take ownership of QMS procedures, work instructions, and forms related to recalls, field actions, field safety notices, and relevant reporting

• Track metrics associated with recall and field action processes

• Conduct assessments for complaint and adverse-event reportability

• Complete evaluations and filings for MDR and vigilance in regions including the United States, Canada, the EU, and others as applicable

• Foster relationships with global regulatory authorities and address inquiries related to field actions and complaints

• Collaborate with manufacturing sites and Quality Engineering on investigations and corrective measures

• Escalate issues to senior management when necessary

• Assist in internal and external audits and inspections, including MDSAP, and help facilitate the resolution of findings

• Identify risks to compliance and opportunities for process improvements

• Adhere to AirLife’s values, quality and safety standards, policies, and guidelines

• Promote a positive team environment and utilize company resources effectively

⛳️ Requirements

• Understanding of medical-device quality standards such as ISO 13485, FDA QSR, EU Medical Device Directives and Regulations, Australian TGA, Japanese PMDA, Brazilian ANVISA, and Canadian Medical Device Regulations

• Proficient knowledge of recall, field safety corrective action, advisory notice, adverse event, and vigilance reporting mandates

• Familiarity with the MDSAP audit model and its expectations

• Strong analytical and project management capabilities

• Capacity to lead time-sensitive, cross-functional initiatives and make informed decisions within regulatory deadlines

• Exceptional verbal and written communication, along with analytical skills

• Strong organizational skills and meticulous attention to detail

• Ability to manage multiple tasks simultaneously

• Systematic approach to problem-solving

• Proficient computer skills, including MS Word, MS Excel with charts and pivot tables, PowerPoint, database management, and statistical analysis

• Ability to work collaboratively and influence across functions

• At least 7–10 years of experience in Quality Systems within an FDA-regulated and/or ISO-certified setting, ideally ISO 13485

• Direct experience in leading or managing product recalls, field corrective actions, or advisory notices

• Clinical experience is advantageous

• Experience with complaint-handling systems

• Familiarity with adverse event reporting, including MDR and vigilance, as well as health hazard or risk evaluation

• Experience in owning or authoring QMS procedures and supporting internal, external, and MDSAP audits is preferred

• Bachelor’s degree or equivalent experience in Engineering, Science, Nursing, a related scientific discipline, or equivalent

• Willingness to travel as business needs dictate

🏝️ Benefits

• Medical coverage

• Dental coverage

• Vision coverage

• 401(k)

• Paid time off

• Paid holidays

• Bereavement leave

• Access to Employee Assistance Program resources

• Medical leave benefits

• Bonus, commission, or other incentive compensation may be available for certain positions

• Travel may be required based on business needs