In this role, you have the opportunity to
This role is responsible for managing regulatory compliance and quality programs at Philips Canada. This role provides regulatory direction to the business regarding regulatory requirements for product launch, submissions and post-market compliance. This includes activities focused on quality systems, product safety, post market surveillance, risk management, field corrections, CAPAs and inspection readiness. This position will also provide project management support for quality and regulatory compliance projects and initiatives. You understand that collaborative, cross functional teams are the most effective, and your communication skills successfully bring these diverse groups together to spawn creative, open-minded and out-of-the-box thinking.
You are responsible for
Manage Daily Management of critical KPIs and leading indicators related to complaint handling, FCO management/implementation, and escalation trending for example.
Understands and applies regulatory requirements and their impacts in reviewing licensing submissions
Supports regulatory inspections as required
Supports and encourages a collaborative, open and team-based culture across organization and the larger Q&R organization
Demonstrate knowledge of Health Canada regulatory and quality requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
Oversee the product hold in alignment with Corporate policies and procedures.
Apply thought leadership and foster a culture of continuous improvement by identifying areas to improve, driving continuous improvement initiatives and utilizing problem solving methodologies to enhance business performance.
Provide ongoing guidance and direction to operations and other business functions regarding regulatory and quality matters.
Responsible to assist in the assessment/confirmation that an adverse event (MDR, Vigilance, MPR) has occurred and then to report to the appropriate agency and/or the authorized representative.
Assist with Field Actions– this may include developing the field action strategy, initiation, communication/notification, monitoring/updates, reporting to Health Canada and closure of the action.
Ensure Philips Medical Device Establishment License (MDEL) is maintained in good standing with Health Canada.
Review and approve local marketing communications for compliance to local regulations
Manage and improve handshake process within business clusters and local marketing
You are a part of
A team that drives Customer Experience into the organization to the support transition to Total Quality Management. You will support all products sold within North America focusing on service and installation within the field. You will work to develop & improve data analysis tools and models for monitoring and assessing product field performance.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in engineering or related field
5+ years of progressive experience in Quality roles
Regulatory Affairs (RAC) Certification is preferred
Experience in project management and practical use/ implementation of Quality Tools
3+ years demonstrated ability to influence in an international business environment
Build trusted relationships internally at all levels across functions
Strong understanding of quality process management
Builds confidence and trust through role modeling behaviors and performance
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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 .
Philips Electronics Ltd is committed to treating all people in a way that allows them to maintain their dignity and independence. We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.