Senior RA Associate Consultant - EU MDR (Medical Devices)

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 Senior Regulatory Affairs Associate Consultant with a focus on EU MDR with REMOTE option in Toronto, Ontario, Canada for 12 months CONTRACT, to join one of our major medical device clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. 

Responsibilities:

 
•    Actively collaborate with the client’s regulatory project team to identify and collect all necessary TF/DD documents in compliance with EU MDR (2017/745) and related guidance (MDCGs) for maintenance and resubmission. The high-level activities may include but are not limited to:

• Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations 
• 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

•    Work with cross-functional teams and affiliates to obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects)
•    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

Minimum Requirements: 

•    Bachelor’s degree (life sciences preferred) 
•    Minimum of 1 year 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)
•    Strong written and verbal English communication skills required

AI Disclosure:

We are using AI as part of the recruitment process. 

Vacancy: 

Advertisement relates to a current vacancy. 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  

Who will you be working for? 

About ClinChoice      

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 Company Ethos 

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.  We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. 

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.

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