Regulatory Affairs - medical devices

Ultra Group AB; Stockholms kommun; On-site; SEK 550,000 - 850,000; Full time

Job summary

Ultra Group AB is seeking a Regulatory Affairs specialist to manage and support medical device registration activities for Class I devices in international markets. You will prepare, review, and compile registration dossiers and supporting documentation, coordinating with local representatives, distributors, consultants, and regulatory authorities.

Responsibilities include tracking registration status and renewals, reviewing labeling and technical documentation, responding to authority queries,

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.

Job description

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