Ortho Clinical Diagnostics

Project Manager – Quality & Regulatory Affairs

2 months ago(31/10/2017 7:29 PM)

The Company

Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

The Opportunity

As the company continues to grow, we are seeking a Project Manager of Quality and Regulatory Affairs to provide pre- and post-market support to the Canadian Regulatory Affairs department in multiple areas, including Quality Systems and Compliance. This position will work closely with cross-functional business partners, as well as US/International Regulatory Affairs and Quality Systems teams, to ensure regulatory compliance with corporate requirements and Canadian regulations throughout the IVDD product lifecycle.

The Responsibilities

Regulatory Affairs

  • Ensure that regulatory strategies meet global and local requirements over the lifecycle of all products.
  • Designated as the main contact point to Health Canada for all QRC activities concerning Ortho Canada.
  • Participate as a regulatory lead by providing regulatory expertise to global and local teams to facilitate successful product launches and escalate issues to business partners that affect registration/regulatory compliance and continued lifecycle management of the products.
  • Prepare and submit IVDD Class II, III and IV regulatory submissions to Health Canada in accordance with CMDR §32-43.
  • Prepare, submit and maintain Investigational Testing Application authorizations in accordance with CMDR §79-88.
  • Prepare and submit F202 Forms for new or modified CMDCAS Quality Systems certificates.
  • Prepare and complete annual reports per CMDR §43.1, annual license renewal packages, Establishment License annual review package and execute applicable fee payments.
  • Communicate and maintain all records of correspondence with Health Canada.
  • Perform change assessments for existing products and determine regulatory strategy as applicable.
  • Conduct Copy Review of international and locally developed promotional materials for compliance to corporate and CMDR/FDCA requirements. Maintain copy review tracking log.
  • Maintain MS Access License Database and Documentable Changes tracking log.
  • Collaborate with Marketing Department concerning new product launches, line extensions, etc.
  • Collaborate with Contracts/RFP Department concerning tender bids and RFP responses.
  • Represent Ortho on the MEDEC Regulatory Affairs Committee(s).
  • Collect, assess and present IVD regulatory intelligence and generate training materials for internal stakeholders as required.


Quality Systems and Compliance

  • Manage, support and participate in internal audits, external ISO13485 CMDCAS audits, and regulatory agency inspections locally and internationally (as applicable).
  • Responsible for execution of all post-market surveillance as part of lifecycle management.
  • Coordinate recall reporting and closure with Health Canada (Section 64 & 65), as well as customer communications and feedback to OCD PMRM Department.
  • Prepare and submit all Mandatory Problem Reports to Health Canada’s Marketed Health Products Directorate.
  • Execute quality holds related to supply chain stop shipments for nonconforming products.
  • Document, evaluate, investigate and close non-conformances and CAPAs related to market and distribution quality incidents, as well as audit deficiencies.
  • Develop and maintain quality system SOPs supporting Canadian regulatory compliance.
  • Support the annual maintenance and closure of Training Plans for Ortho Canada.
  • Assist with complaint investigation when required by the Ortho CHU, distribution center or Customer Service team.

The Individual

Required Competencies

  • Ability to effectively assemble electronic and paper regulatory submissions and packages for Health Canada (MS Word, Adobe Acrobat).
  • Excellent analytical problem solving skills.
  • Expert knowledge of the Canadian Food and Drugs Act and Medical Devices Regulations (SOR/98-282) along with relevant policies and guidance documents applicable to the regulation of medical devices/IVDDs in Canada.
  • Excellent verbal, written, research and presentation skills.
  • Superior computer literacy and keyboarding skills (MS Office, validated EDM systems, Trackwise).
  • Effectively prioritize and complete multiple projects within established timelines.
  • Demonstrated leadership skills.

Desired Competencies

  • Coordinate short-term projects, including project execution, measurement/tracking of milestones, reporting results.
  • Participate in department projects that focus on department goals, new initiatives and process improvements.
  • Ability to interpret difficult situations and determine optimal solutions(s) to ensure stakeholder satisfaction.
  • Ability to work independently or collaboratively within a cross-functional team.

Education and Experience

  • B. Sc degree or quivalent, advanced degree an asset (MSc or PhD).
  • 5-8 years regulatory and quality systems experience within the medical device/IVD industry in Canada.
  • Completion of Post Graduate certification in Regulatory/QA preferred.
  • RAC (CAN) (Regulatory Affairs Certification) preferred.

Working Conditions

  • Office is located in Markham, ON, Canada.
  • Occasional travel may be required (5-10%).#LI-POST


Equal Opportunity

At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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