Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility in Waterdown, Ontario, CA . You should be comfortable working one to two days onsite.

Who we want:

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do:

Individual Responsibilities:

• Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation

• Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance

Functional Responsibilities:

• Conduct product incident follow up, including filing necessary reports with manufacturers and Health Canada in accordance with the Canadian regulations for medical devices, CTOs, cosmetics, drugs, and natural health products

• Coordinates voluntary recalls in accordance with the Canadian regulations for medical devices, CTOs, cosmetics, drugs, and natural health products

• Monitor customer complaints for adverse trends and analyze data to identify opportunities to reduce complaints and improve customer satisfaction

• Support the Quality Management System and operate as a resource for the ISO 9001 Standard and Good Manufacturing Practices requirements for Stryker Canada

• Support the annual internal audit and self-inspection programs and participate in internal audits, as required

• Participate in Third Party Audits and follow up on Corrective Actions

• Coordinate the document control process by ensuring change control and record retention requirements are met.

• Liaise with Corporate RAQA Managers on behalf of Stryker Canada

• Work with all areas within the company (Sales, Operations, and Marketing)

• Work with all regulatory affairs and quality assurance personnel at all manufacturing sites

• Builds good rapport with Health Canada

• Other duties as assigned by Manager

Conduct & Compliance

• Abide by and support the policies set forth in the Stryker Code of Conduct

• Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker

• Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards

• Report any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline Policy

Knowledge & Skill Requirements

• Working knowledge of Canadian Medical Device Regulations and ISO 9001 Standard. Knowledge of Health Canada regulations for Drugs, NHPs, Cosmetics, and Cells, Tissues, and Organs a benefit.

• Strong computer skills (Excel, Word, Power Point, Share point)

• High standard of integrity and ability to meet deadlines

• Highly organized and able to prioritize tasks

• Strong oral and written communication skills with both internal and external contacts

• Ability to make and support decisions with regards to regulatory and quality issues

Education & Qualifications

• University Degree Required. In a science or related field preferred.

• Post-graduate diploma in Regulatory Affairs or Quality Assurance Preferred (completed or in-process)

• 0-2 years of experience in a regulatory affairs and quality assurance environment an asset

• Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered

• Seeks out diverse ideas, opinions, and insights, and applies them in the workplace

• Connects and relates well with people who think and act differently than oneself

• Embraces scrutiny and accepts feedback as opportunity to learn and improve