Regulatory Affairs - medical devices
Manage and support medical device registration activities for Class I devices
We usually respond within 2 hours
Key Responsibilities:
Manage and support medical device registration activities for Class I devices in international markets.
Prepare, review, and compile registration dossiers and supporting documentation.
Coordinate submissions with local representatives, distributors, consultants, and regulatory authorities.
Track registration status, approvals, renewals, and regulatory commitments.
Review product labeling, IFUs, declarations, certificates, and technical documentation.
Support responses to regulatory authority queries and requests for additional information.
Maintain registration databases and regulatory records.
Monitor regulatory requirements and changes in assigned markets.
Markets in Scope:
Latin America
Middle East
Asia-Pacific
Africa
Eastern Europe
If this opportunity is of interest and you are available to start in the near term, please reply with your updated CV and availability.
- Location
- Stockholm
- Remote status
- Hybrid
Colleagues
Stockholm
About Ultra Group AB
Ultra Group is your premier destination for exceptional consulting services across Sweden. We are helping our clients by connecting clients with highly skilled engineers, we ensure top-notch quality and innovative solutions. Our engineers specialize in electrical engineering and software engineering. Our extensive network of consulting firms, driven by engineering expertise, guarantees the best tailored service for all your needs.