Regulatory Affairs Specialist

Job 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 Qualifications
Minimum & Preferred Qualifications and Experience:

• A minimum of 2 years of work experience in a medical device Class II/ III environment.


• 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 and ability to work in a team environment as well as individually with minimal supervision.


• Ability to work in a fast-paced environment, with multiple tasks/projects.


• Ability to work in a Project Team Environment.

Preferred Qualifications

• Experience in patient monitor systems, hospital-based products, software or electronic device products.

+ Knowledge of regulatory submission requirements for India Class II medical devices.
+ Experience in Quality Systems per ISO 13485.

Education
Bachelor’s degree is required, preferably in Engineering or Life Sciences. Graduate degree preferred.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

*Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level*