Regulatory Affairs Specialist Consultant

About this role

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.

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.

Qualifications

• 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