Abbott Regulatory Compliance Specialist – Abbott Medical (Mississauga) in Mississauga, Ontario
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world – in nutrition, diagnostics, medical devices and branded generic pharmaceuticals – that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Status : Regular, Full Time
Position Overview :
Ensure compliance with corporate policies, regulatory and quality requirements related to but not including complaint handling, mandatory medical device problem reporting, device returns, customer letters and field safety corrective actions. Support other areas of the Quality Management System.
Review Product Experience Reports (PERs) for content requirements and reportability to Health Canada.
Correspond with Abbott Medical Canada field personnel, Abbott Product Divisions and Health Canada to ensure compliance with reporting policies and regulations
Submit PERs for Abbott products to Abbott Product Performance Groups (PPGs) and enter into Abbott PER database.
Assess Abbott PERs to determine whether they qualify as reportable as per the Canadian Medical Device Regulations (CMDRs) and establish the appropriate type and timelines for reportability.
Prepare or review Mandatory Medical Device Problem Reports (MDPRs) as per agreement with PPGs, and submit to Health Canada within required timelines.
Assist the Warehouse Team with the processing and shipping of PER devices to ensure that they are returned to the appropriate PPG within the required timelines.
Review Customer Letters prepared by PPG to ensure customer understanding, satisfaction and accuracy of the investigation results
Coordinate and facilitate initial PER training for new SJM Canada staff, and periodic training updates on PER policy and process.
Participate in the execution and follow-up with Field Safety Corrective Actions
Support Regulatory and Quality/Compliance team members to ensure vigilance and compliance requirements are met.
Required Education and Experience:
Bachelor of Science Degree or equivalent.
Completion of a Regulatory Certification Program is an asset.
1-3 years of experience working in a regulated environment in the health sciences industry.
Working knowledge of Canadian Medical Device Regulations.
Computer skills with proficiency with Microsoft Office applications (MS Word, Excel, Access, PowerPoint).
Bilingualism (English and French) is an asset.
Familiarity with confidentiality requirements as they pertain to personal health information.
Previous experience in a medical device and/or cardiology field is an asset.
Working equally effectively in a team environment and independently.
Strong decision-making abilities.
Time management skills and ability to multi-task.
Mindful and respectful of the confidential nature of information regarding patients, customers and the business of Abbott Medical Canada.
Effective verbal, written and presentation skills.
Maintains a focus on continuous quality improvement.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com