Head of Postmarket Surveillance, Oral Healthcare

Philips • Bothell, WA

5d • Hybrid

About The Position

In this role you You are responsible for overseeing all aspects of post-market surveillance, including process implementation, complaint handling, and corrective and removal activities. Your role: Drive monitoring, support enhancement and implementation of post-market surveillance, complaint handling, and correction and removal processes and activities, ensuring compliance with regulatory standards and organizational policies. Drive cross-functional periodic reviews and collaboration with stakeholders, integrating feedback and lessons learned into product development and improvement, processes improvements and strategic initiatives. Analyze and refine key operational metrics and reporting systems and ensure data-driven decision-making for continuous improvement. Lead and oversee quality metrics for trending purposes, and reports on trending, post market surveillance activities, periodic safety reports etc. Lead investigations into product complaints and adverse events, ensure timely reporting, accurate triage, escalation, and resolution, and oversee corrective/removal actions to maintain product safety and regulatory compliance. Lead, manage and develop a multidisciplinary team. Foster a culture of transparency and accountability, mentoring team members and ensuring the effective transfer of knowledge and best practices throughout the organization.

Requirements

• Bachelor's / Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• 5+ years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Nice To Haves

• Risk management experience for medical devices, with thorough knowledge of FMEAs and RMRs
• Minimum 3 years’ prior management or other relevant experience
• Experience with FDA inspection, and/or ISO Audits
• NCR, FSN and CAPA experience is a plus
• Experience in both medical and non-medical is a plus
• Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems

Responsibilities

• Overseeing all aspects of post-market surveillance, including process implementation, complaint handling, and corrective and removal activities.
• Drive monitoring, support enhancement and implementation of post-market surveillance, complaint handling, and correction and removal processes and activities, ensuring compliance with regulatory standards and organizational policies.
• Drive cross-functional periodic reviews and collaboration with stakeholders, integrating feedback and lessons learned into product development and improvement, processes improvements and strategic initiatives.
• Analyze and refine key operational metrics and reporting systems and ensure data-driven decision-making for continuous improvement.
• Lead and oversee quality metrics for trending purposes, and reports on trending, post market surveillance activities, periodic safety reports etc.
• Lead investigations into product complaints and adverse events, ensure timely reporting, accurate triage, escalation, and resolution, and oversee corrective/removal actions to maintain product safety and regulatory compliance.
• Lead, manage and develop a multidisciplinary team.
• Foster a culture of transparency and accountability, mentoring team members and ensuring the effective transfer of knowledge and best practices throughout the organization.

Benefits

• generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• stock purchase plan
• education reimbursement

What This Job Offers

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