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    Regulatory Affairs Specialist - Mississauga, Canada - Apex Systems

    Apex Systems
    Apex Systems Mississauga, Canada

    1 month ago

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    Description

    Regulatory Affairs Specialist

    Apex Systems is searching for a Regulatory Affairs Specialist for our client in Mississauga, ON. Our client is in the Medical Device industry and is looking for someone with a background in medical device regulatory affairs, and experience with ISO 13485 & 14971, regulatory affairs submission in both Canada and the US, technical writing skills, and knowledge of GMP . This position is a rolling 12-month contract opportunity working on the day shift, with possibility of extension or a full-time job offer.

    Client: Medical Device Manufacturer

    Contract: 12-month contract (possibility for extension/conversion)

    Location: Mississauga, ON (3 days/week onsite work required)

    Application Process: Please apply via the medium on which you are seeing this posting. If you encounter technical difficulties submitting your resume, please send a Word version of your resume to Please reference Job Title Regulatory Affairs Specialist

    Responsibilities:

    • Assist with strategy, planning, preparation and submission of medical device license/ registration applications to Health Canada, FDA, and rest of the world countries.
    • Work closely with the supervisor, local regulatory representatives, and distributors to compile regulatory submissions and efficiently respond to review queries from global regulatory agencies.
    • Maintain and update registrations and licenses as required. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, notification of changes and annual updates.
    • Ensure accurate and timely submissions to regulatory agencies.
    • Maintain current knowledge of international regulations, guidance and standards applicable to our client's products and ensure compliance.
    • Research regulatory issues and disseminate regulatory information to Production, QA/QC, and R&D departments and senior management.
    • Assist with regulatory compliance activities such as labeling reviews, post-market reports and clinical evaluation reports.
    • Maintain internal and external regulatory documentation database.
    • Work with cross-functional teams and interface with manufacturing, R&D and quality representatives to provide regulatory assessment and support for new development projects and proposed changes to products and processes, as required.
    • Coordinate activities related to notarization, legalization and authentication of documentation required for regulatory filing.
    • Prepare Regulatory Working Instructions/Flow Processes/Procedures, as required.
    • Ensure all work is in compliance with applicable company standard, ISO standards, GLP, GMP and GCP and established SOPs.
    • Reporting immediately to immediate manager, any variances from the target completion date of the tasks, or that the tasks cannot be completed.
    • Working effectively in collaboration with other members of the department, or with managers and staff across the organization with whom tasks must be completed.
    • Working in a safe manner so as not to endanger individual health and safety, or the health and safety of others.
    • Working to achieve assigned tasks within the standards required (quality, quantity, time and resources).
    • Complying with all legal requirements, all corporate policies and procedures, and with generally accepted business and ethical practices.
    • Performing other duties as assigned by immediate manager.

    Key Qualifications:

    • 2+ years of experience in Regulatory Affairs at a medical device or biomedical company.
    • Specific experience with FDA requirements, guidance documents, 510(k) submissions, ISO 14971 and ISO
    • Post-graduate certificate in a related Regulatory Affairs course is an asset.
    • Strong organizational skills and timeline management.
    • Ability to manage multiple projects, work independently, and flex with changing priorities.
    • Experience with negotiations/ interactions with regulatory agencies.
    • Excellent analytical thinking and problem-solving skills.
    • Demonstrated ability to influence based on experience, facts, and data.
    • Advanced computer skills, e.g., proficient in the Microsoft suite (WORD (create and use templates), EXCEL, and PowerPoint), Adobe Acrobat.

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