Manager, Regulatory Affairs

6 days ago

Mississauga ON, Canada Medline Industries Full time

As a leading partner in healthcare, Medline Canada's sole purpose is Together Improving Care – this means being deeply committed to the health and well-being of our customers, employees, partners and our communities. Market competitive compensation and benefits plan, including LTD & Insurance
Paid vacation and personal days
Lifeworks Employee Assistance Program (EAP) Resources supporting mental, physical, family and financial well-being
Career growth and training programs
Open communication with Senior Leaders
Tailored incentives for eligible employee groups, such as home office reimbursement and Sylvan Learning Centre credit
Social activities
The Manager, QA is responsible for managing the quality and compliance for applicable products and processes. Reporting to: Senior Director, QARA
Position Type: Full-time
Ensure quality and regulatory compliance with applicable regulations (ex. Acts as a liaison with US Product Divisions, GSOs, Suppliers, Manufacturing, and/or L&W to ensure quality products and customer satisfaction.
Identify and manage the execution of continuous improvement projects.
Assist Medline Canada in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
Assist in resolving quality issues to customer satisfaction, in a timely manner.
Resolve issues relating to product or production quality by interfacing with internal and external customers.
At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR).
BSc required in Engineering, Science, or Technical Field.
Experience in Medical Device Industries - Specifically dental, OR/Surgical Instrument or Orthopaedic preferred
Broad technical knowledge of relevant standards and regulations (Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
With 550+ employees, including 100 dedicated sales and clinical professionals and eight distribution centres located coast-to-coast, Medline Canada is proud to serve the entire continuum of care.
Our Commitment to Diversity and Inclusivity
Medline Canada is committed to diversity and inclusivity and we encourage applications from members of groups that have been historically disadvantaged and marginalized, including First Nations, Metis and Inuit peoples, Indigenous peoples of North America, racialized persons/persons of colour and those who identify as women, persons with disabilities and LGBTQ+ persons.
Medline Canada is committed to the principles of the Accessibility for Ontarians with Disabilities Act (AODA). We endeavor to make our recruitment, assessment and selection processes as accessible as possible and provide accommodations as required for applicants with disabilities. however, Canadians and permanent residents will be given priority.

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