Sr. Regulatory Affairs Associate - CONSULTANT

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 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

• Basic 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 Regulatory Compliance EU MDD/MDR

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