Regulatory Affairs Specialist

Pall Corporation; Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Benefits offered by this job

Health care

Paid time off

Remote work

Job summary

Pall Corporation in Bengaluru seeks a Regulatory Affairs specialist to obtain Indian regulatory clearances for Masimo medical devices and to serve on project teams for new products or changes. You will support APAC filings, draft technical files, and coordinate registrations with health authorities.

Role requires 2+ years in a medical device Class II/III environment and India-specific regulatory experience; remote-friendly arrangements are possible for eligible roles.

Qualifications

• Minimum of 2 years’ experience in a medical device Class II/III environment.
• Local Indian regulatory experience in the medical device industry.
• Working knowledge of IT equipment import/export rules and BIS certification application process.

Responsibilities

• Obtain and document Indian regulatory clearances for Masimo medical device products.
• Serve as the sole Regulatory Affairs representative on project teams for new products or product changes.
• Support the APAC regulatory team in managing international and domestic filings/registrations, including drafting and compiling technical files, tender request submissions, and responding to audit findings.
• Communicate with the headquarters regulatory team on local regulation changes and conduct impact assessments.
• Assist global regulatory representatives with filings and responses to inquiries from health authorities.
• Maintain product listings and establishment registrations with Indian regulatory authorities.

Job description

ROLE

• – Obtain and document Indian regulatory clearances for Masimo medical device products.
• – Serve as the sole Regulatory Affairs representative on project teams for new products or product changes.
• – Support the APAC regulatory team in managing international and domestic filings/registrations, including drafting and compiling technical files, tender request submissions, and responding to audit findings.
• – Communicate with the headquarters regulatory team on local regulation changes and conduct impact assessments.
• – Assist global regulatory representatives with filings and responses to inquiries from health authorities.
• – Maintain product listings and establishment registrations with Indian regulatory authorities.

REQUIREMENTS

• – Minimum of 2 years’ experience in a medical device Class II/III environment.
• – Local Indian regulatory experience in the medical device industry.
• – Working knowledge of IT equipment import/export rules and BIS certification application process.
• – Ability to travel as needed.

BENEFITS

• – Comprehensive competitive benefit programs, including health care and paid time off.
• – Flexible remote working arrangements for eligible roles.