Product Complaint Associate Manager

About This Role

This role manages Post Market Surveillance (PMS) staff and ensures compliance with Boston Scientific's complaint handling program, aligning with corporate, domestic, and international regulations. It involves overseeing risk management, driving patient safety, and maintaining product quality within the medical device industry.

Responsibilities

• Escalate and participate in resolution of potential product deficiencies for all applicable BSC products
• Ensure site operational procedures support corporate policies and guidance while aligning with regulations and standards
• Manage performance and professional growth and development of staff
• Monitor daily work operations to achieve company, division and project goals by providing direction and guidance to staff
• Maintain processes and procedures for ensuring compliance to corporate policies, external regulations, and standards
• Ensure compliance with US & OUS regulatory requirements for medical devices for complaint handling and regulatory reporting
• Participate in the Global Quality Community to improve post market quality across multiple divisions
• Coordinate parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders
• Provide clear communication on deliverables, timelines and milestones
• Influence change and align stakeholders to make decisions with limited information

Requirements

• Minimum bachelor’s degree in a related field
• Minimum of 5 years of medical device industry, pharmaceutical, or diagnostic device experience
• Proven people leadership experience of minimum 3 years in a similar capacity – 4 or direct reports
• Demonstrated experience or collaborating and communicating with regulatory bodies
• Proven ability to manage shifting priorities in a dynamic environment

Qualifications

• Bachelor’s degree in a related field
• Minimum of 5 years of medical device industry, pharmaceutical, or diagnostic device experience and 3 years of people leadership experience

Nice to Have

• Boston Scientific experience
• Experience with operational excellence – process optimization, problem solving, Six Sigma, lean methodologies
• Experience working with competent authorities and notified bodies – FDA, BfArM, HPRA, etc.
• Experience with Interventional Cardiology and Vascular Therapy products
• Experience with Post Market activities – complaints, vigilance, CAPA
• Experience supporting internal or external audits
• Vendor management experience – oversight and execution of post -market process

Benefits