Regulatory Affairs Specialist Consultant

ClinChoice•Canada, ON

1d•CA$1 - CA$2•Hybrid

About The Position

ClinChoice is seeking a Regulatory Affairs Specialist Consultant for a 12-month contract, with a hybrid option in Canada, to join one of our major consumer products clients. This role offers the opportunity to work directly for a single sponsor while benefiting from the security and career opportunities of a global CRO. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and a supportive culture.

Requirements

Minimum of three years of working experience in regulatory affairs in preparing and reviewing technical documentation and submissions per Health Canada medical device regulations
Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
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

Nice To Haves

Basic knowledge of EU MDR and ISO13485 or equivalent education is preferred.

Responsibilities

Prepare, review, and support medical device registration submissions and post-market regulatory activities.
Document review of product changes and the management of any required submissions.
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.
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.
Filing and retrieving documents 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.
Participating in group meetings and provide tactical approaches to addressing issues of basic complexity.
Descriptive but not limitative all activities related with implementation (Labeling, Change control, SOPs).
Work with relevant cross functional teams to collect the required documents.
Other duties as assigned.