• Job Description

  Req#: R524817
  Work Flexibility: Hybrid

  Stryker is currently seeking a Post Market Specialist (Hybrid) Waterdown, Ontario, CA. This is a permanent role.

  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

  Travel Percentage: None

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

Notice