QA Engineer for SIMBA Team ensuring functional coverage and quality. Collaborating closely with engineering and product teams while maintaining organized QA documentation.
ML
Director, Quality Assurance – Regulatory Affairs
Posted 2 months ago
About the role
- Director overseeing Regulatory Affairs and Quality Assurance at Medline Canada. Ensuring compliance and strategic direction within the company for regulatory and quality issues.
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.
Requirements
- 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).
Benefits
- 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…
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