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Sr. Regulatory Affairs Associate – Consultant at ClinChoice - ApplyBlast

Sr. Regulatory Affairs Associate – Consultant

ClinChoice

1 month ago

3.3 on Glassdoor

Remote

Contract

Senior

0 applicants

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About this role

This role involves collaborating with the regulatory project team to review, update, and create Technical Documents in compliance with EU MDR and other global medical device regulations. The position requires working independently to establish a high-trust environment with clients while managing cross-functional teams and health authority inquiries. It offers the security of a global CRO with the focus of working directly for a single sponsor.

Responsibilities

Review and update Technical Documents in accordance with EU MDR and global regulatory requirements
Perform quality control checks to verify document completeness and accuracy
Collaborate with cross-functional teams to obtain supporting documents and address health authority inquiries

Skills

About ClinChoice

clinchoice.com

Headquarters

Horsham, Pennsylvania, United States

Company Size

1001-5000 employees

Founded

1995

View Profile

ClinChoice is a full‑service global contract research organization (CRO) that helps accelerate drug and medical device approvals to market. They offer end‑to‑end clinical development, regulatory strategy, and operational support across study design, execution, data management and safety to guide sponsors through all phases of development. With global site networks, therapeutic expertise and data‑driven processes, ClinChoice aims to shorten timelines and reduce risk for development programs. They partner with biotech, pharma and device companies to navigate complex regulatory pathways and bring safer products to patients.