In this role, you have the opportunity to
Manages the field action/recall program and serves as the Business Process Expert (BPE) for Philips’ Image Guided Therapy Device (IGT-D) business unit.
You are responsible for
Lead activities to update field action processes to the Philips standardized processes (PEPF). Activities include, but are not limited to, creating or updating quality transition plans, coordinating and assuring availability and resources of SMEs within each Quality System, and driving execution of activities defined in the quality transition plans.
Be the primary point of contact to develop and influence corporate Philips processes to manage field action activities
Develop and implement a harmonized field action process for IGTD
Manage the field action process for IGT-D including initiation, customer and regulatory notification, and product withdrawal
Work with cross-functional team to coordinate required documentation of field actions
Prepare customer letters, summary field action status reports, and communications to regulatory agencies and competent authorities for field actions
Support Product Impact Evaluations and Health Hazard Evaluations (HHEs) to ensure risk assessment and analysis are consistent across products and systems within IGTD.
Assemble a response team and coordinate activities to develop and implement the appropriate field action plan.
Notify senior company management, corporate law, corporate communications and other internal stakeholders of field action/recall; including markets and distribution partners.
Coordinate Recalls, communicate with government regulatory agencies and maintain records of actions taken.
Manages recall responses, recall file documentation and recall file completion.
Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions.
Ensure that processes for executing field actions are compliant to global regulatory requirements and meet internal quality system requirements.
Monitor and coordinate the different quality sub-system feeders to the field action process such as Complaint Handling, CAPA, Postmarket Surveillance, Risk Management, and Nonconforming Materials processes.
Provides relevant feedback and insights from customers/ filed to development/ engineering teams to ensure learnings from previous projects are captured, synthesized and made available for next project teams.
Continuously tracks field actions and provide ongoing information to regulatory operations and Field action teammates as required.
Establishes, monitors and reports on metrics on the efficacy and efficiency of field action processes.
Timely submission of field action KPIs for IGTD
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Bachelor’s degree in healthcare or science fields
5+ years of managing field actions in the medical device industry
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, European Medical Device Directive (93/42/EEC), European Medical Device Regulation (EU MDR 2017/745 EU) Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, Brazilian Resolution RDC 23, and Therapeutic Goods Act 1989.
Strong written and oral communication skills are required
Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
Problem-solving and proficient computer skills are required
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to provide guidance to multiple facilities supporting field action processes
Ability to leverage and/or engage others to accomplish projects
Experience working in a broader enterprise/cross-division business unit model preferred
Ability to work in a matrixed and geographically diverse business environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 10%, potentially internationally
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.