Regulatory Affairs medical devices
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Monthly Salary:
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Job Summary
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.
About Company
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 softwa ... View more
