Clinchoice Inc.

Clinchoice Inc.

Regulatory Affairs Specialist Consultant

Canada

Sponsorship not specifiedDetected 6 days ago
AccessibilityExcelFDA RegulatoryMedical DevicesCommunicationCritical ThinkingOrganizational SkillsMicrosoft OfficeRegulatory Affairs

About the role

  • Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?
  • Our team says it's the best of both worlds….
  • ClinChoice is searching for a Regulatory Affairs Specialist Consultant with Hybrid/Remote option in CANADA until 31st Decemeber 2026, to join one of our major consumer products clients.

Responsibilities

  • Prepare and/or review of letters of authorizations, cover letters for registration certificates, declarations, power of attorney, etc., to ensure accuracy, appropriateness and consistency of documents intended for various regulatory submissions.
  • Extract available documents from the document management databases and operational systems to assist in the preparation of dossiers.
  • Maintain various tracking tools to ensure up to date information and traceability of all regulatory data/documentation.
  • Filing and retrieving documents as directed and per company's policies and procedures.
  • Provide support to internal and external teams to address various technical inquiries and provide requested information.
  • In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA"), personal information is collected under the authority of the Act and will only be used for candidate selection.

Requirements

  • Strong organizational skills including attention to detail, good planning and communication skills are required
  • Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
  • We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
  • The ideal candidate will also have a strong understanding of EU MDR and ISO13485.
  • Minimum of three years of working experience in regulatory affairs in preparing and reviewing technical documentation and submissions per Health Canada medical device regulations
  • Basic knowledge of EU MDD/MDR and ISO13485 or equivalent education is preferred.
  • Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
  • Have good understanding of current Good Documentation Practices in regulatory environment
  • Must possess excellent written and verbal communication skills
  • Detail oriented with strong critical thinking and analytical skills and keen on producing results
  • Who will you be working for?
  • About ClinChoice
  • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
  • Our Company Ethos

Compensation

  • The base salary pay range represents the anticipated low and high range for this position.
  • Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
  • Canada Pay Range

Benefits

  • We are seeking a Regulatory Affairs professional with at least three years of hands-on experience preparing, reviewing, and submitting technical documentation in compliance with Health Canada medical device regulations.
  • Prepare, review, and support medical device registration submissions and post-market regulatory activities.
  • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
  • Join our passionate team and make a meaningful impact on global healthcare!

Company info

  • to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
  • Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel.
  • The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.
  • The success of these core values is evidenced by our below industry average turnover rates.
  • ClinChoice is an equal opportunity employer.
  • We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity.
  • We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

Equal opportunity

  • ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.

Visa & Work Authorization

  • Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?
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This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.