Senior Manager Regulatory Affairs

elemed; Paris; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

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.
• Good level of English (written/oral).

Responsabilités

• 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.
• Ensure Regulatory Affairs files are maintained to support regulatory compliance.

Connaissances

Regulatory strategies development

U.S. FDA submissions

Design control

Project management

Clinical investigation

Good level of English (written/oral)

Technical skills

Outils

FDA submissions process

Description du poste

🔎 Title: 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.

🔹 As a Regulatory Affairs Consultant your mission is to:

• 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]

📲 Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/

Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.

Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

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🩺 Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.

📣 We won Best International Recruitment Agency at the Recruiter Awards 2021.

At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.

⚖️ 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.