Director, Quality Assurance & Regulatory Affairs (QARA)

Value Proposition 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. We employ a diverse group of top talent focused on growing and making a difference in the lives of Canadians, coast-to-coast.

Compensation is only one part of the Employee Value Proposition that Medline Canada offers our employees. As part of our mission, we offer one of the most competitive and engaging employee experience programs in Canada, which includes:

Collaborative work environment with highly engaged employees

Market competitive compensation and benefits plan, including LTD & Insurance

DPSP match program

Annual Employee Appreciation Week

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

Employee referral program

Education support programs

Fitness subsidy

Recognition programs

Social activities

And much more…

Job Description Summary Reporting to the Sr. Director, International Regulatory at Corporate, this position is responsible for overseeing and directing Regulatory Affairs staff to ensure the proper labelling, licensing, registering, listing and submitting for clearance or approval of Medline facilities and/or products. Implement regulatory compliance activities or government affairs activities. This position also provides leadership to Quality Assurance staff, directing best QA practices to development and drives process improvements.

Job Description Responsibilities

Oversees all quality and regulatory activities at Medline Canada to obtain regulatory clearance and maintain compliance with regulations and quality system requirements to support the growth and success of the company.

Provides recommendations and strategic direction to the President Medline Canada and Senior Leadership Team on regulatory and quality issues that affect business continuity.

Responsible for implementing and ensuring compliance to Medline’s Quality System relative to Medline Canada operations and for maintaining GMP compliance in all facilities.

Directs all QA/RA employees in Canada (Guelph and Terrebonne) to ensure each functional area operates efficiently to serve the needs of the company, specifically in:

Regulatory applications to Health Canada for devices, drugs, natural health products and others;

Due diligence on new product setup in alignment with established corporate processes;

Importation of Drug and NHP products in accordance with GMP regulations;

Sale and distribution of prescription drugs;

Maintenance of the complaint handling system and incident reporting to Health Canada;

Conducting recall activities in a timely and effective manner;

Development and maintenance of SOPs in alignment with corporate processes and Heath Canada/ISO regulations;

Training of all employees in accordance with Medline’s Reliance documentation system to ensure compliance with Quality System and GMP requirements.

Develop and issue regular Management Review Reports to ensure senior management are aware of the status of quality and regulatory activities.

Develop and maintain effective relationships with Medline Corporate to gain support for the QA/RA activities at Medline Canada.

Represent Medline Canada to Health Canada authorities and other regulatory bodies

Provide support and guidance to internal customers on communications with external customers on matters of regulatory or quality concern.

Ensure institutional knowledge of the requirements for Medline product submissions for regulatory authority clearance by working with vendors, internal customers and consultants as needed.

Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes;

Build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies.

Qualifications

Bachelor of Science degree

Minimum 10 years of progressive experience with a medical device company and/or pharmaceutical company working in combination Regulatory Affairs and Quality Assurance.

At least 5 years of experience managing people, including hiring, developing, motivating and directing people as they work.

Excellent knowledge and interpretation of Health Canada regulations.

Excellent ability to read and interpret other regulations affecting Medline Canada products.

Excellent written and verbal communication skills in English.

Ability to work effectively independently as well as in a team environment managing multiple priorities in a fast-paced environment.

Excellent ability to analyze and resolve complex issues and recommend strategies to resolve problems.

Ability to present and communicate with various audiences.

Proficiency in computer skills (Microsoft Office, experience with SAP is an asset).

The anticipated salary range for this position: $143,400.00 - $215,000.00 Annual

This job description is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization.

Medline Canada, Corporation is proud to be an equal opportunity employer.

About Medline Canada Medline Canada stands at the forefront of healthcare, providing expertise and a breadth of solutions for every care setting. 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.

Our Commitment to Accessibility Medline Canada is committed to the principles of the accessibility in Canada. We endeavour to make our recruitment, assessment and selection processes as accessible as possible and provide accommodations as required for applicants with disabilities. If you require any accommodations at any point during the application and hiring process, please contact HRCanada@medline.com.

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.

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