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
workplace.
* 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” attitude

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Masimo
📍 Bengaluru