Regulatory Affairs Specialist Consultant

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.

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
• 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
• 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
• Who will you be working for?
• About ClinChoice
• Our Company Ethos

Benefits

Additional Information

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 option in CANADA for 12 months CONTRACT and renewable , to join one of our major consumer products clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. Role : Regulatory Affairs Specialist Consultant Employment Type: Contract Location: Hybrid/Canada : 2 To 3 Days a week 6675 Millcreek Dr Unit 2, Mississauga, ON L5N 5R8 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. The ideal candidate will also have a strong understanding of EU MDR and ISO13485. This position requires a strong team player who can work across various cultures and departments to meet team, company, and client goals and assigned objectives.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at clinchoice? Share your experience