Global Medical Device Regulatory Specialist

Dynavox Group AB; Stockholms kommun; Hybrid; SEK 600.000 - 800.000; Vollzeit

Zusammenfassung

Dynavox Group AB is seeking a Global Regulatory Specialist for the Quality & Regulatory Affairs team. This hybrid position involves ensuring that medical devices meet global regulatory requirements. Responsibilities include streamlining regulatory processes and maintaining technical documentation in compliance with EU and FDA standards.

The ideal candidate will have a bachelor's degree in a related field and at least 5 years of experience in medical device regulatory affairs. The role requires strong communication and organizational skills, and proficiency in English is a must.

Qualifikationen

• 5+ years of experience in medical device regulatory affairs.
• Hands-on experience with EU MDR (Class I) and FDA QSR.
• Proficient in English communication.

Aufgaben

• Streamline regulatory processes and set a roadmap.
• Coordinate with auditors for audit readiness.
• Maintain and update technical documentation.

Kenntnisse

Regulatory Affairs

Problem-solving

Communication skills

Collaboration

Organization

Ausbildung

Bachelor's degree in Regulatory Affairs, Life Sciences or related field

Tools

Regulatory systems

Document control tools

QMS platforms

Jobbeschreibung

Dynavox Group AB is seeking a Global Regulatory Specialist for the Quality & Regulatory Affairs team. This hybrid position involves ensuring that medical devices meet global regulatory requirements. Responsibilities include streamlining regulatory processes and maintaining technical documentation in compliance with EU and FDA standards.

The ideal candidate will have a bachelor's degree in a related field and at least 5 years of experience in medical device regulatory affairs. The role requires strong communication and organizational skills, and proficiency in English is a must.