Senior Regulatory Affairs Specialist, Global Submissions

Cure Talent; Crewe; Presencial; GBP 50.000 - 70.000; Jornada completa

Descripción de la vacante

Cure Talent is seeking a Senior Regulatory Affairs Specialist in Crewe, England, to join a renowned medical device company. In this hands-on role, you'll support regulatory strategies, manage global submissions, and ensure compliance with EU MDR and US FDA regulations. Successful candidates will have strong experience in regulatory affairs and document review, supporting continuous improvement processes. Join the team and contribute to life-saving technologies in an impactful environment.

Formación

• Proven experience within Regulatory Affairs in the medical device sector.
• Strong working knowledge of EU MDR and US FDA frameworks, including Technical Documentation and 510(k) submissions.
• Experience helping to define regulatory strategy alongside hands-on submission and documentation activity.

Responsabilidades

• Help define regulatory strategy for product portfolios.
• Lead detailed review of regulatory documentation.
• Prepare and support global submissions including EU MDR and US FDA 510(k).
• Act as a key regulatory contact in cross-functional teams.
• Support regulatory interactions with authorities and audits.

Conocimientos

Regulatory Affairs experience

Knowledge of EU MDR

Knowledge of US FDA frameworks

Document review

International registrations

Descripción del empleo

Cure Talent is seeking a Senior Regulatory Affairs Specialist in Crewe, England, to join a renowned medical device company. In this hands-on role, you'll support regulatory strategies, manage global submissions, and ensure compliance with EU MDR and US FDA regulations. Successful candidates will have strong experience in regulatory affairs and document review, supporting continuous improvement processes. Join the team and contribute to life-saving technologies in an impactful environment.