Manager, Complaint Handling & Safety Reporting

Job TitleManager, Complaint Handling & Safety Reporting

Job Description

We welcome you to join Volcano a Philips Company as a Manager, Complaint Handling & Safety Reporting in either our Rancho Cordova or San Diego, CA locations. Should you be hired in our San Diego location, travel to Rancho Cordova will require approximately two weeks out of the month.

In this role, you have the opportunity to work with a cutting edge product line - IGT Devices is part of the Philips Image Guided Therapy (IGT) business group. As the Manager of Complaint Handling & Safety Reporting, you will be managing the Complaint Handling and Adverse Event Reporting process within the IGT Devices business.

As a strong leader you will be capable of inspiring your stakeholders as well as managing internal and external relations. You will make a difference, can drive change and add a positive contribution to our business process in a dynamic role.

At this time, Company relocation benefits will not be provided for this position. Candidates need to live within commuting distance to either Rancho Cordova or San Diego.

The Complaint Handling and Adverse Event processes and activities are mainly related to Customer Complaints and safety reporting, supporting Post Market Surveillance activities, and supporting internal and external audits/inspections.

You are responsible for

  • Provide daily leadership to team members concerning complaint handling activities, reportability assessments and regulatory filing requirements
  • Generate, revise and/or implement robust and compliant complaint handling and medical device reporting procedures
  • Develop and implement training materials and train associates on all procedures, policies and guidelines
  • Review adverse event reporting determinations to ensure they meet domestic and international regulatory requirements (FDA, MEDDEV, CMDCAS, ISO, etc.) prior to submission, when required
  • Develop and implement complaint event tracking and trending data collection tools
  • Provide data, trending and detailed analysis to support regulatory submissions
  • Ensure complaint handling target metrics are met on a routine basis and escalate issues, when required
  • Lead, develop and implement corrective and preventive actions to address complaint handling and medical device reporting issues, as required
  • Identify and implement, business process efficiencies to ensure timeliness metrics are consistently met Act as Subject Matter Expert for all complaint handling responsibilities
  • Directly support all external domestic and international inspections and audits as well as internal audits
  • Lead and/or facilitate formal response team activities to ensure all regulatory responses are submitted on time
  • Complete documentation associated with personnel performance reviews and communicate personnel reviews to team members. Develop personnel goals and objectives
  • Lead project activities and associated action items regarding on-going complaint handling improvement efforts
  • Routinely interact with Q&R, R&D, Manufacturing, Customer Service and Clinical in order to ensure robust complaint investigations are conducted
  • Assess critical events and elevate and engage appropriate management, when required

You are a part of

Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.

To succeed in this role, you should have the following skills and experience

  • Management and strong leadership skills in a challenging working environment with a proven track record of 3+ years of experience in managing and transforming a large team
  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169
  • Bachelor's degree preferably in Engineering or Science
  • 6+ years of related experience in a medical device or regulated industry preferably in complaint handling, adverse event reporting and related processes.
  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Strong interpersonal and communication skills at all levels in the organization, a real people manager
  • Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways
  • Strong written and oral communications skills
  • High reliability and quality focus
  • High engagement, motivation and flexibility

Good understanding of customer needs

In return, we offer you

We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people's lives every day.

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. Learn more by watching this video

Find out more info about Philips at www.philips.com/na/careers

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

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