Associate Manager, Product Surveillance

About the role

As Associate Manager, Product Surveillance, you will provide tactical and strategic leadership for the Product Surveillance Associates, overseeing both technical and safety-related complaints. You will coordinate, manage, and review complaints, ensuring compliance with Good Documentation Practices and global regulations, while also leading risk management and post-market initiatives. This role involves managing a team, driving process improvements, and serving as a Quality Business Partner for commercial and customer relationships.

Responsibilities

• Act as a stream lead for all aspects of the complaint process and coordinate with Global Product Safety to evaluate and investigate patient-related complaints.
• Document consistent and compliant safety and reporting assessments.
• Lead post-market initiatives, including compiling and assessing data for PSUR and other reports.
• Lead risk management activities, including review and coordination of post-market data.
• Review, approve, and close complaints in accordance with applicable SOPs.
• Manage the training program by developing, coordinating, and delivering training.
• Maintain and update departmental metrics and reporting; conduct statistical analysis of complaint trends and drive actions, including product updates or changes.
• Serve as the point of escalation and Quality Business Partner for commercial and customer relationships related to the complaint handling process.
• Develop solutions to complex problems and identify corrective actions.
• Proactively identify and implement operational changes to improve efficiencies in complaint handling.
• Drive continuous improvement initiatives and projects in Product Surveillance, as well as items arising from complaint data.
• Support or conduct investigations associated with product deviations, non-conformances, CAPAs, scrap, and rework; analyze data for quality improvement and reporting.
• Originate, review, and approve internal operating procedures and specifications through the Document Change process.
• Support or lead the development, verification, and validation of product changes and the introduction of new products as they relate to post-market surveillance.
• Lead internal quality system audits and support or participate in external quality system audits.
• Evaluate complaints and determine if submission of a Medical Device Report (MDR) or other Vigilance Report is required; submit reports according to regulatory timelines.
• Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.
• Articulate a clear and compelling vision aligned with global cultural tenets and strategic objectives; define roles and responsibilities while holding team members accountable.
• Develop talent and skills of individual team members and empower leaders and employees to make informed decisions.

Minimum Qualifications

• Bachelor’s Degree
• 2+ years of quality experience in Medical Device, Pharmaceutical, and/or equivalent regulated industry

Preferred Qualifications

• Experience with post-market surveillance and complaint handling
• Supervisor or Lead Experience

Knowledge, Skills, and Abilities

• Familiarity with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
• Strong technical and general problem-solving skills; experience with NCR/CAPA processes
• Understanding of medical and/or scientific terminology
• Professional phone etiquette with the ability to appropriately handle sensitive information
• Proficiency in Microsoft Office Suite, Adobe, and Quality System Management Software
• Highly organized with strong attention to detail
• Highly effective communication skills, including written and verbal
• Proven leadership skills with the ability to manage and direct teams and projects, ensuring successful outcomes and effective collaboration
• Ability to work with company staff and communicate effectively throughout the organization
• Strong time management skills with proven ability to prioritize and manage multiple records/reports simultaneously