Product Complaint Associate Manager

Boston Scientific • Arden Hills, MN

19h

About The Position

Your responsibilities will include: Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards. Manages performance and professional growth and development of staff Provide clear communication on deliverables, timelines and milestones Coordinates and participates in escalation of adverse complaint trends or product issues Ensure appropriate training is provided to the Post Market Surveillance staff

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
• Proven experience supporting internal or external audits
• Proven vendor management experience - oversight and execution of post -market process

Nice To Haves

• Preferred experience with operational excellence - process optimization, problem solving, Six Sigma, lean methodologies
• Proven experience working with competent authorities and notified bodies - FDA, BfArM, HPRA, etc.
• Proven experience with Interventional Cardiology and Vascular Therapy products
• Preferred experience with Post Market activities - complaints, vigilance, CAPA

Responsibilities

• Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards.
• Manages performance and professional growth and development of staff
• Provide clear communication on deliverables, timelines and milestones
• Coordinates and participates in escalation of adverse complaint trends or product issues
• Ensure appropriate training is provided to the Post Market Surveillance staff

What This Job Offers

• Job Type: Full-time
• Career Level: Manager