Senior Associate - Regulatory Affairs (EU MDR)
ClinChoice
About this role
A Regulatory Affairs Specialist supporting maintenance and resubmission of medical device technical files and design dossiers under EU MDR (2017/745). The role ensures regulatory compliance, documentation readiness, and coordination with project teams and affiliates throughout the submission process.
Skills
Qualifications
About ClinChoice
clinchoice.comClinChoice 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.
Recent company news
Fierce BiotechClinChoice raises $150M in series E round as CRO outlines growth plan and potential IPO
Jul 6, 2022
Pharmaceutical TechnologyClinChoice enhances global reach with CSI Medical acquisition
Jan 12, 2024
PR NewswireClinChoice Acquires CROMSOURCE, Expanding its Global Presence
Mar 1, 2023
PatchClinChoice Opens International Headquarters In Horsham
Dec 26, 2024
Bloomberg.comGoldman-Backed ClinChoice Is Said to Consider Hong Kong IPO
Jul 6, 2023
About ClinChoice
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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Salary
$46k – $62k
per year