[Hiring] Sr. Regulatory Affairs Associate Consultant @ClinChoice

Role Description

ClinChoice is searching for a Sr. Regulatory Affairs Associate – CONSULTANT for a 12 months Contract with possibility of extension to join one of our clients.

As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Responsibilities:

• Actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements.
• Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements.
• Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations.
• Draft, create or update TDs in collaboration with Platform RA SME.
• Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files.
• Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders.
• Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages.
• Verify TD documents are approved and contain the most recent revision(s).
• Work with the cross-functional teams and Company’s local affiliates to obtain necessary supporting documents.
• Respond to inquiries from the Company’s local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–related questions or requests.
• Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required.
• Attend meetings and communicate with the project team as appropriate.
• Routinely communicate with regulatory management team regarding project status and deliverables.
• Support other regulatory activities as assigned.

Qualifications

• Bachelor’s degree (life sciences preferred).
• Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR.
• Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory.
• Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint).
• Self-starter with ability to work in team environment and projects of diverse scope.
• Strong organizational skills including attention to detail, good planning and communication skills are required.
• Strong written and verbal English communication skills required.

Requirements

• Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR.
• Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory.
• Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint).

Benefits

• Competitive salary range: $40 — $44 CAD.
• Possibility of contract extension.

Company Description

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.