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 Sr.Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

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

Job Title: Sr. Regulatory Affairs Associate- CONSULTANT

Location: Mexico - Remote

Responsibilities:

Actively collaborate with the client’s regulatory project team to collect all necessary TF/DD documents for resubmission. The high-level activities may include but are not limited to:
- Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements
- Identification of applicable regulatory requirements, standards, guidance, and submission requirements relevant to the project
- 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 per client’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc.
- Verify TF/DD documents are approved and contain the most recent revision(s)
Work with the local affiliates to respond to queries and obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects)
Notify and coordinate with the leadership of any health authority related questions
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
Communicate daily or weekly with regulatory management team regarding project status and deliverables

Minimum Requirements:

Bachelor’s degree (life sciences preferred)
Minimum of 1 year of working experience in Medical Device Regulatory Affairs/ training in Regulatory Affairs focused on EU MDR
Knowledge of FDA Medical Device regulations, ISO13485, EU MDD/MDR
Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
Strong proficiency in written and verbal English communication is required.

Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR, ISO 13485, US FDA QSR

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