Regulatory Affairs Analyst
Summary
The Regulatory Affairs Analyst supports regulatory activities required to obtain and maintain medical device approvals in the US and European markets. This role works closely with cross-functional teams to prepare submissions, maintain regulatory documentation, and support compliance throughout the product lifecycle.
Responsibilities
Prepare, compile, submit, track, index, and archive regulatory submissions and supporting documentation for medical devices.Support regulatory submissions including (k), IDE, PMA, HDE, annual reports, technical documentation assessments, design examinations, and change notifications.Maintain regulatory records, technical files, design dossiers, letters to file, and regulatory impact assessments.Assist in responding to regulatory authority questions, deficiency letters, and other agency correspondence.Review product labelling, packaging, a...