Description

Titre du poste
Quality-Regulatory Specialist

Description de poste

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

Your role:

• Work with a variety of diverse persons and teams 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)
• 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.

You're the right fit if:

• 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

• Experience working directly with Health Canada
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

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 .

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .

Philips Transparency Details

The annual pay range for this position is $63,000 to $99,000. 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. Details about our Canada benefits can be found here .

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

Canadian work authorization is a precondition of employment. 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.

Philips Canada 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.