Senior Regulatory Affairs Consultant MedTech FDA

elemed; Paris; On-site; EUR 70,000 - 110,000; Full time

Job summary

A leading MedTech recruiter in France seeks a Senior Regulatory Affairs Consultant. The successful candidate will develop regulatory strategies, manage FDA submissions, and ensure compliance for medical devices. Ideal candidates have 5-7 years of experience, strong project management skills, and are proficient in English. Join a dynamic midsize company and contribute to innovative medical solutions. Competitive salary and a supportive work environment await you.

Qualifications

• 5-7 years of experience in a regulatory affairs position for medical devices.
• Experience in project management and submission of FDA 510(k).
• Great technical skills and operational excellence.

Responsibilities

• Develop and execute regulatory strategies/plans that comply with global regulatory requirements.
• Lead U.S. FDA submissions.
• Ensure Regulatory Affairs files are maintained for compliance.

Skills

Regulatory strategies development

U.S. FDA submissions

Design control

Project management

Clinical investigation

Good level of English (written/oral)

Technical skills

Job description

A leading MedTech recruiter in France seeks a Senior Regulatory Affairs Consultant. The successful candidate will develop regulatory strategies, manage FDA submissions, and ensure compliance for medical devices. Ideal candidates have 5-7 years of experience, strong project management skills, and are proficient in English. Join a dynamic midsize company and contribute to innovative medical solutions. Competitive salary and a supportive work environment await you.