Quality-regulatory Specialist

3 weeks ago

Mississauga, Canada Philips Full time

**Job Title**: Quality-Regulatory Specialist

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

Contribute to Philips mission to Accelerate Patient Safety and Quality through performing foundational post-market surveillance and quality activities. The primary focus of this role is to ensure timely reports of post market vigilance activities such as adverse events, safety events, recalls and any post market information requests according to regulatory requirements. Write and submit medical device reports, consumer incident reports and recalls. Ensures all post market regulatory requirements are met.

This role will also have the opportunity to support CAPA investigations, service escalations, and transformation projects.

**Your role**:

- Work with a variety of diverse persons to facilitate reportable device events in accordance with written procedures and global reporting requirements.
- Prepare and submit Consumer Incident Reports to Health Canada as required and maintain all records
- Prepare and submit Mandatory Problem Reports to Health Canada as required and maintain all records.
- Determine reportability decision for recalls in Canada and prepare and submit recall report (Health Systems, Personal Health)
- Monitor and improve tracking/control systems for medical device reporting.
- Investigate and prepare responses to address Competent Authority inquiries and provide follow-up.
- Manage and execute product field actions and product holds when quality issues are identified.
- Ensure Philips Medical Device Establishment License (MDEL) is maintained in good standing with Health Canada.
- Participate in the coordination of external government audits and Philips Global quality audits.
- Provide regular reports of quality management system metrics for post-market activities.
- Manage radiation servicing notifications.
- Coordinate timely reporting of any post market information requests (generally at the BIU)
- 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.
- Provide ongoing guidance and direction to operations and other business functions regarding quality matters.
- Provide support to CAPA investigations, service escalations, and transformation projects.
- Learn the Philips’ Excellence tools, such as PRIDE problem solving and Daily Management activities.

**You're the right fit if**:

- Minimum of 3+ years work experience in quality or regulatory affairs role in medical devices, pharmaceutical or health care industry
- Working knowledge of Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Cosmetics and Consumer Regulations, and relevant standards and guidelines
- Experience working directly with Health Canada
- Strong interpersonal skills, facilitation and influencing skills with an ability to work effectively with internal and external stakeholders
- Communicate messages clearly and concisely with the ability to make decisions with speed and accuracy based on the best available information / ability to sift through complex information and focus on critical few priorities
- Ability to coordinate, contribute to and work within a cross-functional team
- Bachelor’s degree in sciences, engineering or health care related field
- Regulatory Affairs Certification (RAC) is a plus.
- Problem solving and continuous improvement mindset

**About Philips**

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.

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