Description
Duties & Responsibilities:
- Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.
- Communicate with headquarter regulatory team on local regulation changes with impact assessment.
- Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.
- Assist in maintaining product listings and establishment registrations with India regulatory authorities.
- Familiar with BIS requirements and supporting import/exports for medical devices.
- Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements.
- Maintain up-to-date knowledge on international and domestic regulatory requirements.
- Provide regulatory support to the OEM Product Management team
- Submit sales market change orders (SMCO/agile) for approvals.
- Support impact assessment for changes anticipated by Corporate.
- May represent RA department in project meetings and provide regulatory guidance.
- Update RA responsible quality system procedures as required (SQP/SOP’s);
- Performs other duties or special projects as assigned.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
- A minimum of 2 years of work experience in a medical device Class II/ III setting.
- Local Indian Regulatory experiences in medical device industry are required
- Working knowledge of IT equipment import/export rule and BIS certs application process.
- Computer Proficiency with MS Office (Word/Excel/Access/Outlook).
- Excellent verbal and written communication skills.
- Excellent prioritizing, organizational, and interpersonal skills.
- Excellent documentation skills including record maintenance/ tracking and understand document traceability.
- A detail-oriented individual with a “can do”