Post Market Specialist

2 months ago

Hamilton, Ontario, Canada Stryker Full time

We are excited to be named one of the World's Best Workplaces by Fortune Magazine

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

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

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.


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