Senior Regulatory Affairs Consultant — EU MDR (Remote Contract)

ClinChoice; United States; Remote; USD 80,540,000 - 88,594,000; Full time

Job summary

ClinChoice is seeking a Sr. Regulatory Affairs Associate – CONSULTANT for a 12-month contract to join one of our clients. The candidate will work with cross-functional teams to review, draft, and QC Technical Documents in line with EU MDR and other regulatory requirements.

The role requires strong English communication, regulatory proficiency, and the ability to work independently in a client-facing environment. This contract offers professional development within a global CRO setting.

Qualifications

• Bachelor’s degree in life sciences (or related field) is required.
• 2+ years of Regulatory Affairs experience focusing on EU MDR.
• Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations.

Responsibilities

• Collaborate with regulatory project team to review and create Technical Documents (TDs) per EU MDR.
• Identify applicable regulatory requirements and submission expectations.
• Draft or update TDs with Platform RA SME and perform QA checks.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

ClinChoice is seeking a Sr. Regulatory Affairs Associate – CONSULTANT for a 12-month contract to join one of our clients. The candidate will work with cross-functional teams to review, draft, and QC Technical Documents in line with EU MDR and other regulatory requirements.

The role requires strong English communication, regulatory proficiency, and the ability to work independently in a client-facing environment. This contract offers professional development within a global CRO setting.