Senior Regulatory Affairs Lead – Med Device FDA Submissions

elemed; Les Ulis; On-site; EUR 70,000 - 110,000; Part time

Job summary

A healthcare technology firm is seeking a Senior Regulatory Affairs Consultant to develop and execute regulatory strategies compliant with global requirements. The role requires leading FDA submissions and managing design controls. Ideal candidates should have 5-7 years of experience in regulatory affairs for medical devices and a good level of English. This is an exciting opportunity to be part of a midsize innovative company in the medical equipment sector. Applications can be sent via email.

Qualifications

• 5-7 years of experience in a regulatory affairs position for medical devices.
• Experience in project management and submission of FDA 510(k).
• Good level of English (written/oral).

Responsibilities

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

Skills

Regulatory strategies development

U.S. FDA submissions

Design control management

Clinical investigation

Project management

Fluent English (written/oral)

Technical skills

Operational excellence

Job description

A healthcare technology firm is seeking a Senior Regulatory Affairs Consultant to develop and execute regulatory strategies compliant with global requirements. The role requires leading FDA submissions and managing design controls. Ideal candidates should have 5-7 years of experience in regulatory affairs for medical devices and a good level of English. This is an exciting opportunity to be part of a midsize innovative company in the medical equipment sector. Applications can be sent via email.