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67 Philips Jobs
RA Specialist
Philips
posted 2hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Supporting RA Team for the Indian Sub Continent to ensure on time registrations, monitoring and assessment of changes in regulations, review of product changes and regulatory assessment, ensure compliance to applicable regulations.
- Responsible for planning, supporting RA Submissions, approvals, renewals and compliance to applicable act and rules under following ministries-
1. Ministry of Health (CDSCO) - D&C Act and Medical Device Rules,
b PC&PNDT Act and Rules
2. Atomic Energy Regulatory Board;
3. Ministry of Communication and IT (DOT)- Wireless Approvals
4. Bureau of Indian Standards- ISI Marking and Accessories required to comply with METY registration order (Registration marking registration Scheme)
5. Ministry of Environment and Forest- Preowned Medical Equipment
7.Ministry of Electronics And IT- (MIETY)
12. Ministry of Chemicals and Fertilizers- NPPA Compliance as per Drugs Price Control Order (Notified Medical Devices are regulated as Non-Scheduled formulation)
13. NMRA (Sri Lanka) -National Medicine Regulatory Authority
14. DGDA (Bangladesh) - Directorate General Drug Administration
- Support RA manager for Operations / supply chain in addressing regulatory queries from customs
- Support to Govt Sales team in addressing regulatory queries/ clarifications
- Support to customers query with regards to AERB compliance, customs with regards to CDSCO, AERB, BIS act and rule compliance
- Coordinate with regulators, test lab and govt for facilitation of clearance from BIS for electronic accessories.
To succeed in this role, you should have the following skills and experience
- A university degree in Science or Engineering with minimum of 6 - 10 years experience in Regulatory Affairs with -
- Working knowledge of relevant India and international medical device regulations ( CDSCO, BIS, AERB, MIETY, MOEF, Min of Consumer Affairs, Ministry of Chemicals and Fertilizers, and Ministry of Health (PC&PNDT)
- Knowledge of Health Care standards applicable to Diagnostic X ray, Electric safety, risk management, software related standard (Global & Local Standard)
- Problem solving skills for regulatory, quality and product safety issues.
- Demonstrated ability to balance business needs and regulatory perspective.
- Able to develop strong relationships with their country Competent regulatory body(ies) to support open communication with regards to vigilance and recalls, as appropriate
- Knowledge of ISO 13485 & 9001, 60601 and other standards
Employment Type: Full Time, Permanent
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What people at Philips are saying
Specialist salary at Philips
reported by
9
employees
with 2-10
years exp.
₹4.4
L/yr - ₹13
L/yr
30%
less
than the average Specialist Salary in India
View more details
What Philips employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Philips Benefits
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Philips Gurgaon / Gurugram Office Locations
Gurugram Office
9th Floor, DLF 9-B, DLF Cyber City, DLF Phase - 3, Sector 25
Gurugram
Haryana 122002
Haryana 122002
Gurgaon Office
9th Floor, DLF 9-B, DLF Cyber City,, Sector 25, DLF Phase - 3
Gurgaon
Haryana 122002
Haryana 122002
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