Senior Manager Regulatory Affairs

elemed; Les Ulis; Sur place; EUR 70 000 - 110 000; Temps partiel

Résumé du poste

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).
• Strong understanding of Regulatory Affairs for medical devices.
• Clinical investigation experience and strong English communication.

Responsabilités

• 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.
• Maintain Regulatory Affairs files to support compliance.

Connaissances

Regulatory strategies development

U.S. FDA submissions

Design control management

Clinical investigation

Project management

Fluent English (written/oral)

Technical skills

Operational excellence

Description du poste

Senior Regulatory Affairs Consultant

The Company:

If you are a QA/RA professional with an interest in innovation and groundbreaking development, we have an incredible role for you. This is a chance to join an established midsize Software as a Medical Device company.

Role Responsibilities & Qualifications:

• Develop and execute regulatory strategies/plans that comply with global regulatory requirements
• Lead U.S. FDA submissions
• Lead Design control and design change activities
• Ensure Regulatory Affairs files are maintained to support compliance with regulatory requirements
• 5-7 years of experience in a regulatory affairs position for medical devices
• Experience in project management and submission of FDA 510(k)
• Experience in clinical investigation
• Good level of English (written/oral)
• Great technical skills and operational excellence

✉️ If you are interested in this exciting role, please send your application directly to [e-mail]

📲 For more opportunities, visit https://www.elemed.eu/vacancies/

⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Quality Assurance

Industries: Medical Equipment Manufacturing and Biotechnology Research

Location: Boulogne-Billancourt, Île-de-France, France