- 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, postmarket reports and clinical evaluation reports.
- Maintain internal and external regulatory documentation database.
- Work with crossfunctional 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.
- 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 1348
- Postgraduate 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 problemsolving 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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Immediate Start Regulatory Affairs Specialist - Mississauga, Canada - Apex Systems
Description
Regulatory Affairs SpecialistApex 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:
Key Qualifications:
