Sr. Regulatory Affairs Associate- Consultant

Clinchoice; A distancia; MXN 1,093,000 - 1,458,000; Jornada completa

Descripción de la vacante

A global full-service CRO is seeking a Senior Regulatory Affairs Associate Consultant for a 12-month contract. This role involves collaborating with regulatory project teams, ensuring compliance with EU MDR, and maintaining communication regarding project status. The ideal candidate should have a Bachelor's degree in life sciences, at least a year of experience in regulatory affairs, and strong English communication skills. A commitment to quality and a supportive environment are part of the company's culture.

Formación

• 1+ years of experience in Medical Device Regulatory Affairs or training in Regulatory Affairs focused on EU MDR.
• Basic knowledge of ISO and EU MDD/MDR.

Responsabilidades

• Collaborate with the client's regulatory project team to collect necessary documents.
• Maintain knowledge of EU MDR and other global regulatory requirements.
• Perform quality-control checks per client's procedures.

Conocimientos

Knowledge of FDA MedTech regulations

Proficient in Microsoft Office

Strong written and verbal English communication

Educación

Bachelor's degree in life sciences

Descripción del empleo

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 a 12‑month contract with the 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 a supportive culture.

As a client‑facing role, we are looking for confident candidates who can work independently while establishing a high‑trust environment with the client's counterparts.

Job Title

Senior 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.
• Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements.
• Identify 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 the client's procedures/training/checklist (e.g., verify all pages are present, no blank pages).
• Verify TF/DD documents are approved and contain the most recent revisions.
• Work with local affiliates to respond to queries and obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and supporting documents from projects).
• Notify and coordinate with leadership regarding any health‑authority related questions.
• Represent Regulatory Affairs on project teams and report regulatory requirements in the required frequency, format, and sequence.
• Attend meetings and communicate with the project team as appropriate.
• Communicate daily or weekly with the regulatory management team regarding project status and deliverables.

Minimum Requirements

• Bachelor's degree (life sciences preferred)
• Minimum of 1 year of experience in Medical Device Regulatory Affairs or training in Regulatory Affairs focused on EU MDR
• Basic knowledge of FDA MedTech regulations, ISO, and EU MDD/MDR
• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
• Strong written and verbal English communication skills are required

Preferred Qualifications

• Training in EU MDD/MDR