Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job Title

Regulatory Affairs Specialist

Job Description

Job title: Regulatory Affairs Specialist

Your role:
Regulatory Affairs Specialist – ISC  will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with  product registration in the India Sub Continent, actively providing value-added regulatory affairs service and deliverables for existing products, new product introductions and product changes across the ISC.  supporting SAP Regulatory controls to ensure products are safe, effective, and meeting the target market Regulatory requirements.

You are responsible for

• 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. Atomic Energy Regulatory Board

2. Ministry of Communication and IT (DOT)- Wireless Approvals\Ministry of Communication and IT (DOT)- Wireless Approvals

3.Ministry of Health (CDSCO) – D&C Act and Medical Device Rules

4.PC&PNDT Act and Rules

5. Bureau of Indian Standards- ISI Marking and Accessories required to comply with METY registration order (Registration marking registration Scheme)

6. Ministry of Environment and Forest- Preowned Medical Equipment 

7.Ministry of Electronics And IT- (MIETY)

8. Ministry of Chemicals and Fertilizers- NPPA Compliance as per Drugs Price Control Order (Notified Medical Devices are regulated as Non-Scheduled formulation)

9. NMRA (Sri Lanka) -National Medicine Regulatory Authority

10. 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 Bachelor's degree in Bio Medical Engineering with minimum of 6 - 10 years’ experience in Regulatory Affairs with - ( Engineering degree - mandatory)

• 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

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our commitment to inclusion and diversity

At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation , and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.