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 valueadded 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 SubContinent 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 NonScheduled 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 a 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 &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 newlyadopted 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 fulltime 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 (LGBTQ ) 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 problemsolving.

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 casebycase basis.

We want to be at our best: The way we work and our workspaces are designed to support our wellbeing 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 customerfirst health technology solutions. Help us improve the health and wellbeing of billions of people every year. Ultimately creating a career that no one could have planned for. Even you.