Executive Regulatory Affairs - Pune, Maharashtra, India - Fusion Market Research

Fusion Market Research

Verified Company

Pune, Maharashtra, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Write, analyze, and edit technical documents to support countryspecific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe.

Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.

Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
Assist in preparing response to regulatory authorities questions within assigned timelines.
Stay abreast of regulatory procedures and changes in regulatory climate.
Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
Other duties as assigned.