18/11 HR
HR at Operon Strategist

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Regulatory Affair Specialist - Medical Device (2-3 yrs)

Pune Job Code: 19909

Job description

Regulatory Affairs Specialist

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.

Duties and Responsibilities

1. Write, analyze, and edit technical documents to support country-specific 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

2. Assist in preparing responses to regulatory authorities' questions within assigned timelines.

3. Stay abreast of regulatory procedures and changes in the regulatory climate.

4. Assess device-related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required.

5. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.

6. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

7. Other duties as assigned.

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