Regulatory Affairs Associate

The specialist will prepare, review, and maintain regulatory documentation medical devices, equipment, and related supplies, ensuring alignment with global and local regulations. Day-to-day responsibilities include interpreting regulatory requirements, supporting regulatory submissions, coordinating with cross-functional teams (clinical operations, supply chain, quality assurance), and maintaining up-to-date regulatory records and databases. The role involves monitoring regulatory changes across relevant markets, assessing their impact on ongoing and planned studies, and advising internal stakeholders on compliance strategies. The specialist will also contribute to the development and continuous improvement of regulatory processes and standard operating procedures.
Qualifications
Candidates should possess strong skills in Regulatory Affairs, including familiarity with regulatory frameworks for clinical trials and medical devices.
Candidates should possess skills in Regulatory Documentation and Regulatory Submissions, including the ability to prepare, review, and compile dossiers and filings.
Candidates should possess skills in Regulatory Compliance and Regulatory Requirements, with the ability to interpret guidelines and ensure adherence across projects.
Solid understanding of clinical development processes and supply chain considerations in regulated environments.
Experience working with international regulations and standards (e.g., ISO, GDPMDS, and relevant health authority guidelines) is beneficial.
Strong analytical, organizational, and time-management abilities, with attention to detail and accuracy in documentation.
Effective written and verbal communication skills, with the ability to collaborate across multidisciplinary teams.

Work arrangement
No