Quality&Regulatory Affair’s Officer

Quality-Regulatory Specialist
Contribute to Philips mission of better care for more people through performing foundational post-market surveillance and quality activities, as well as supporting the pre-market approvals process. 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. This role will also have the opportunity to support pre-market submission reviews, CAPA investigations, service escalations, and transformation projects
report (Health Systems, Personal Health)
~ Manage and execute product field actions and product holds when quality issues are

Ensure Philips Medical Device Establishment License (MDEL) is maintained in good

Bachelor’s degree in sciences, engineering, health care, regulatory or equivalent. Regulatory Affairs Certification (RAC) is a plus.
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
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
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 commitment to diversity and inclusion here.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, DC Pension, Flex Dollars (for HSA/PSA/RRSP), stock purchase plan, education reimbursement and much more. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside within commuting distance to the Philips office in Mississauga, ON.
We welcome and encourage applications from people with disabilities.