Quality Assurance Regulatory Affairs Specialist

1 month ago


Markham, Ontario, Canada fluidigm Full time

Job Title: Quality Assurance Regulatory Affairs Associate

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Assurance Regulatory Affairs Associate to join our team. The successful candidate will be responsible for maintaining and ensuring that our company's quality system meets requirements for medical devices and international directives.

Key Responsibilities:

  • Maintain Technical Documentation files in compliance with international requirements.
  • Oversee the company REACH and Safety Data Sheet program.
  • Approval and release of Quality Records, Device History Records, Batch Records Master Labels and Device Master Records.
  • Support and administration of risk assessment review process and implementation of changes to risk management process as needed.
  • Liaison with domestic and international customers and vendors to ensure compliance with standards and execution of corrective actions.
  • Development of controlled documents and procedures pertinent to Quality Assurance activities and functions.
  • Assists with customer complaints/CAPA system.
  • Supports new product development, risk analysis, and launch processes, and manage QA participation on new production development.

Requirements:

  • Bachelor's degree required, life science/engineering.
  • Regulatory Affairs/Quality Management RAC certificate is preferred.
  • Experience with ISO 13485, ISO 9001, required.
  • Knowledge of and experience with the following standards: IEC 60601-1, ISO 13485, ISO 14971, IEC 62366, IEC 62304, CE-IVDR and 21 CFR 820.
  • Knowledge with REACH, RoHS, WEEE, CE mark, UKCA directives and Safety Data Sheet compliance.
  • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/OE).
  • 1-2 years of industry experience preferred.
  • ISO 13485 Internal Auditor certificate a plus.
  • Salesforce Experience a plus.
  • Basic knowledge of Excel.
  • Fast learner, self-starter, accountable, reliable.
  • Ability to successfully work in a dynamic environment.
  • Able to work under pressure and tight timelines.
  • Problem solving attitude.
  • Cross-functional perspective and coordination.

What We Offer:

We are committed to providing an inclusive and barrier-free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform us of your requirements. We are an equal opportunity employer.



  • Markham, Ontario, Canada fluidigm Full time

    Job Title: Quality Assurance Regulatory Affairs SpecialistAt Fluidigm, we are seeking a Quality Assurance Regulatory Affairs Specialist to support the development and implementation of quality and regulatory strategies for our products.Key Responsibilities:Maintain technical documentation files in compliance with international requirements.Oversee the...


  • Markham, Ontario, Canada fluidigm Full time

    Job SummaryWe are seeking a Quality Assurance Regulatory Affairs Specialist to support the quality and regulatory activities of our products. The successful candidate will be responsible for maintaining and ensuring that our quality system meets requirements for medical devices and international directives.Key ResponsibilitiesMaintain Technical Documentation...


  • Markham, Ontario, Canada fluidigm Full time

    Job Title: Quality Assurance and Regulatory Affairs AssociateJob Summary:We are seeking a highly motivated and detail-oriented Quality Assurance and Regulatory Affairs Associate to join our team at Standard BioTools. The successful candidate will be responsible for maintaining and ensuring that our company quality system meets requirements for medical...


  • Markham, Ontario, Canada fluidigm Full time

    About Standard BioToolsWe are a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.Our technology empowers customers to improve life through comprehensive health insight, and we invite you to join us in this extraordinary time.Job DescriptionThis role is responsible for maintaining...


  • Markham, Ontario, Canada fluidigm Full time

    Quality Assurance and Regulatory Affairs Associate RoleWe are seeking a Quality Assurance and Regulatory Affairs Associate to support our products' quality and regulatory activities.The selected candidate will be responsible for maintaining and ensuring that our company quality system meets requirements for medical devices and international directives.Key...


  • Markham, Ontario, Canada fluidigm Full time

    Enhance Quality and Compliance in a Dynamic EnvironmentWe are seeking a highly motivated Regulatory Assurance Specialist to join our team at Standard BioTools. This exciting opportunity will enable you to leverage your expertise in quality management and regulatory affairs to drive business growth while ensuring compliance with industry standards.About the...


  • Markham, Ontario, Canada Kenvue Full time

    Job OverviewWe are seeking a highly motivated Regulatory Affairs Intern to join our team at Kenvue. As a Regulatory Affairs Intern, you will be responsible for supporting the development and implementation of regulatory strategies to ensure compliance with various regulations and laws.


  • Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs Intern RoleKenvue is currently recruiting for a Regulatory Affairs Intern to join our team.This position reports to the Associate Manager, Regulatory Affairs and is based at Markham, ON, Canada.The Regulatory Affairs Intern will be responsible for preparing submissions, responses to regulatory body queries, and filing annual renewal...


  • Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternThis role is part of the Regulatory Affairs team at Kenvue, a global leader in the development and manufacturing of consumer goods.The Regulatory Affairs Intern will be responsible for preparing submissions to regulatory bodies, responding to queries, and filing annual renewal packages.Key Responsibilities:Prepare submissions to...


  • Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternThis position reports to Associate Manager, Regulatory Affairs and is based at Kenvue.This position is a 12-month term.Key ResponsibilitiesPrepares submissions (e.g., NHP PLAs, DIN submissions, SNDSs, NCs, Level III notifications, Class II medical device applications/amendments, cosmetic notifications forms)Prepares responses to...


  • Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternThis position reports to Associate Manager, Regulatory Affairs and is based at Markham, ON, Canada.This position is a 12-month term from 9/2024-9/2025.Key ResponsibilitiesPrepares submissions (e.g., NHP PLAs, DIN submissions, SNDSs, NCs, Level III notifications, Class II medical device applications/amendments, cosmetic notifications...


  • Markham, Ontario, Canada PrimeVest Canada Inc. Full time

    Job Title: Regulatory Compliance SpecialistOverview:PrimeVest Canada Inc. is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring that our company complies with all relevant laws and regulations.Languages:EnglishEducation:Bachelor's degreeExperience:5 years or...


  • Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs Intern RoleKenvue is currently recruiting for a Regulatory Affairs Intern to join our Regulatory Affairs team.This position reports to the Associate Manager, Regulatory Affairs and is based at Markham, ON, Canada. The position is a 12-month term from September 2024 to September 2025.About UsAt Kenvue, we realize the extraordinary power of...


  • Markham, Ontario, Canada fluidigm Full time

    At Fluidigm, we're building a positive culture where our people can do the best work of their careers.About the RoleWe're seeking a Quality Assurance and Regulatory Affairs Associate to support the products' quality and regulatory activities.The successful candidate will be responsible for maintaining and ensuring that our company quality system meets...


  • Markham, Ontario, Canada Bayshore HealthCare Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Bayshore HealthCare. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance across our organization.Key ResponsibilitiesDevelop and implement quality standards and systems to...


  • Markham, Ontario, Canada Bayshore HealthCare Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Bayshore HealthCare. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance across our organization.Key Responsibilities:Develop...


  • Markham, Ontario, Canada SGS Full time

    Job Title: Quality Assurance SpecialistSGS is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring that our clients receive high-quality services that meet their needs and expectations.Key Responsibilities:Review and approve CCRs and manage SOP review and approval...


  • Markham, Ontario, Canada PrimeVest Canada Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at PrimeVest Canada Inc. The ideal candidate will have a strong background in business management and regulatory affairs, with a proven track record of developing and implementing quality management and quality assurance standards.Key ResponsibilitiesAnalyze and...


  • Markham, Ontario, Canada Bayshore HealthCare Full time

    Quality Assurance Specialist SeniorJob SummaryThis role is responsible for ensuring that all aspects of the Quality Management System for Bayshore HealthCare are in compliance with regulatory requirements and industry standards.Main ResponsibilitiesDevelop and implement quality standards, systems, and metrics to ensure regulatory compliance.Collaborate with...


  • Markham, Ontario, Canada Bayshore HealthCare Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Bayshore HealthCare. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance across our organization.Key Responsibilities:Develop...