Regulatory Affairs Specialist

3 days ago

Toronto, Ontario, Canada ClinChoice Full time
Regulatory Affairs Specialist - DEL

at ClinChoice (View all jobs)
Toronto, Canada

Regulatory Affairs Associate Consultant - Canada

Responsibilities:
  • Responsible for new or post market support for local medical device/drug establishment license registrations (MDEL/DEL) and product license registrations
  • Responsible for the documents review of product changes and the management of any required submissions.
  • Responsible for preparation 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 database and operational systems to assist in the preparation of the dossiers.
  • Ensure compliance with current good documentation (cGDP) practices including but not limited to proof reading, formatting, indexing, record keeping, etc.
  • Assist team members in answering inquiries and providing required documents and information utilizing various search tools and systems.
  • Maintain various tracking tools to ensure up to date information and traceability of all regulatory data/documentation.
  • Document filing and retrieval functions as directed and per company's policies and procedures.
  • Effectively communicate with internal and external teams and/or clients as to the status of deliverables to ensure timely and satisfactory completion of tasks and expectations.
  • Provide support to internal and external teams to address various technical inquiries and provide requested information.
  • Participate in group meetings and provide tactical approaches to addressing issues of basic complexity.
  • Work with relevant cross functional teams to collect the required documents.
  • Descriptive but not limitative all activities related with implementation (Labeling, Change control, SOPs).
    Experience/Qualifications:
    • Minimum of three years of working experience in Regulatory Affairs in preparing and reviewing technical documentation and submissions per local regulations.
    • Basic knowledge of Health Canada regulations (as applicable), ISO13485, Canada Regulatory Affairs certification or equivalent education is preferred.
    • Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint).
    • Fluency in English.
    • Have good understanding of current Good Documentation Practices in regulatory environment.
    • 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.
    • Must possess excellent written and verbal communication skills.
    • Detail oriented with strong critical thinking and analytical skills and keen on producing results.

      The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):

      ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling x 301.

      We thank all applicants for their interest; however, only those being considered for an interview will be contacted. 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.

      #LI-JH1 #REMOTE #CANADA

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