Current jobs related to Quality Assurance and Regulatory Affairs Specialist - Markham, Ontario - fluidigm

  • Quality Assurance Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Quality Assurance Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Quality Assurance and Regulatory Affairs Specialist

    1 week ago

    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...

  • Quality Assurance Regulatory Affairs Specialist

    2 weeks ago

    Markham, Ontario, Canada fluidigm Full time

    Job Title: Quality Assurance Regulatory Affairs AssociateJob 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...

  • Quality Assurance/Regulatory Affairs Associate

    1 month ago

    Markham, Ontario, Canada fluidigm Full time

    Job Title: Quality Assurance/Regulatory Affairs AssociateJob 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 quality system meets requirements for medical devices, and International Directives. This...

  • Quality Assurance/Regulatory Affairs Associate

    1 month ago

    Markham, Ontario, Canada fluidigm Full time

    Job Title: Quality Assurance/Regulatory Affairs AssociateJob 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 quality system meets requirements for medical devices, and International Directives. This...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    4 weeks ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    1 month ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will play a key role in supporting the development and implementation of regulatory strategies for our products.Key Responsibilities:Prepare and submit regulatory documents, including NHP PLAs, DIN...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    1 month ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    4 weeks ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    4 weeks ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    1 month ago

    Markham, Ontario, Canada Kenvue Full time

    Regulatory Affairs InternKenvue is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will be responsible for preparing submissions, responding to regulatory body queries, and performing assessments to determine regulatory requirements for new projects.Key Responsibilities:Prepare...

  • Regulatory Affairs Specialist

    2 months ago

    Markham, Ontario, Canada Kenvue Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team at Kenvue. As a Regulatory Affairs Intern, you will be responsible for supporting the preparation of regulatory submissions, responding to regulatory body queries, and maintaining various regulatory databases.Key ResponsibilitiesRegulatory Submissions:...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Regulatory Affairs Specialist

    2 weeks ago

    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...

  • Quality Assurance Specialist

    3 weeks ago

    Markham, Ontario, Canada SGS Full time

    Job DescriptionSGS is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products and services meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesReview and approve CCRs and manage SOP review and approval processResponsible...

  • Quality Assurance Specialist

    3 weeks ago

    Markham, Ontario, Canada SGS Full time

    Job DescriptionSGS is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products and services meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesReview and approve CCRs and manage SOP review and approval processResponsible...

Quality Assurance and Regulatory Affairs Specialist

3 months ago

Markham, Ontario, Canada fluidigm Full time

Quality Assurance/Regulatory Affairs Associate

At Fluidigm, we are at the forefront of advancing life sciences through innovative technologies that provide essential insights into health. We are dedicated to fostering a culture that empowers our employees to excel in their roles, guided by our core principles:

  • Prioritize customer satisfaction in all endeavors
  • Take ownership and fulfill commitments
  • Promote ongoing enhancement
  • Collaborate effectively as a unified team, encouraging open communication and a supportive atmosphere

We are seeking a Quality Assurance/Regulatory Affairs Associate to contribute to our quality and regulatory initiatives. This role is crucial in ensuring that our quality management system adheres to the necessary standards for medical devices and international regulations. The QA/RA Associate will also be tasked with verifying that our products and their associated labeling comply with all relevant regulatory frameworks.

Key Responsibilities:

  • Maintain technical documentation in accordance with global standards.
  • Manage the REACH and Safety Data Sheet compliance program.
  • Approve and release quality records, device history records, batch records, master labels, and device master records.
  • Support and oversee the risk assessment review process, implementing necessary changes to the risk management strategy.
  • Act as a liaison with domestic and international clients and suppliers to ensure adherence to compliance standards and effective execution of corrective measures.
  • Develop controlled documents and procedures relevant to quality assurance operations.
  • Assist in managing customer complaints and the CAPA system.
  • Support new product development, risk analysis, and launch processes, ensuring QA involvement in new product initiatives.

Required Qualifications:

  • Bachelor's degree in life sciences or engineering.
  • Preferred certification in Regulatory Affairs/Quality Management (RAC).
  • Familiarity with ISO 13485 and ISO 9001 standards is essential.
  • Knowledge of standards such as IEC, ISO 13485, ISO 14971, IEC 62366, IEC 62304, CE-IVDR, and 21 CFR 820.
  • Understanding of REACH, RoHS, WEEE, CE mark, UKCA directives, and Safety Data Sheet compliance.
  • ASQ certification is advantageous but not mandatory (e.g., CQA, CQE, CMQ/OE).
  • 1-2 years of relevant industry experience is preferred.
  • ISO 13485 Internal Auditor certification is a plus.
  • Experience with Salesforce is beneficial.
  • Basic proficiency in Excel.
  • Must be a quick learner, self-motivated, accountable, and dependable.
  • Ability to thrive in a fast-paced environment.
  • Capacity to work effectively under pressure and meet tight deadlines.
  • Strong problem-solving skills.
  • Ability to work with a cross-functional perspective and coordinate effectively.

Fluidigm is committed to providing an inclusive recruitment process that accommodates applicants with accessibility needs. We are an equal opportunity employer.