Job Information
Philips Regulatory Affairs Global Regulations Specialist in Gurgaon, India
Job title:
The Regulatory Affairs Global Regulations Specialist is responsible for leading global regulatory monitoring through system implementation, ensuring prompt communication and action on updates. The role coordinates international regulatory strategy implementation, aligning with business goals and facilitating cross-functional collaboration. The role has responsibilities including managing compliance with country-specific product regulations, overseeing submissions, and fostering positive regulatory agency relationships. The role analyzes regulatory changes, provides strategic recommendations to senior management, guides product teams on compliance, utilizes metrics for continuous improvement, communicates updates internally, and enhances compliance processes based on best practices and regulatory shifts
Your role:
Leads the process of staying updated on global and regional regulatory requirements for products by implementing monitoring systems ensuring all regulatory updates are accurately communicated and acted upon, and integrating findings into regulatory strategies.
Coordinates the implementation of global and regional regulatory strategies for international markets by working closely with cross-functional teams, developing comprehensive plans, and ensuring that all regulatory activities align with the organization’s strategic goals and meet local regulatory requirements.
Ensures organizational compliance with country-specific regulations for product registration and commercialization by managing the entire regulatory submission process, overseeing the review and approval of documentation, maintaining local establishment registrations, and addressing any issues or concerns promptly and effectively.
Coordinates relationships with regulatory agencies by maintaining regular communication, attending industry events, representing the organization in regulatory discussions and negotiations, and ensuring positive and productive interactions that facilitate smooth regulatory approvals.
Tracks, interprets, and communicates changes in regulations across different countries by leveraging advanced analytical tools, assessing the potential impact on the organization, providing strategic recommendations and detailed reports to senior management, and updating regulatory strategies to ensure ongoing compliance.
Offers expert guidance on regulatory strategy and requirements to product design teams for new products and solutions, supporting regulatory planning for new product introductions and changes, ensuring continuous compliance with both global and regional regulations throughout the product lifecycle.
Utilizes metrics and key performance indicators to meticulously assess and continuously improve the performance of the Global Regulatory Affairs function, facilitating informed decision-making, strategic action planning, and driving ongoing advancements that align with the organization’s regulatory and business objectives.
Coordinates local testing required to support regulatory submissions by ensuring that all necessary tests are conducted in compliance with local regulations, collaborating with internal teams to accurately document and submit testing data, and ensuring that submissions are complete and compliant.
Communicates updates on global and regional regulatory requirements and changes to internal stakeholders, providing clear guidance on compliance implications, supporting strategic adjustments, and ensuring all relevant teams are informed and aligned with the latest regulatory expectations.
Enhances regulatory compliance processes and procedures by identifying opportunities for improvement, implementing enhancements based on industry best practices and regulatory changes, and ensuring that all compliance processes remain effective, efficient, and aligned with both global and local standards.
Supports stakeholders in the region with regulatory and compliance documentation for new product introductions, reviews marketing materials to ensure consistency with approved claims, intended use, and regulatory positioning, and ensures that all promotional content aligns with local regulatory standards.
Liaises with the Post Market Surveillance team to ensure awareness of all communications with regulators, supports any required escalations related to regulatory issues, and contributes to maintaining compliance by providing necessary documentation and strategic insights.
Supports with manufacturing licenses for L4L activities and other activities as needed.
You're the right fit if: (4 x bullets max)
1. Experience- 10+years of experience in Regulatory Affairs for Medical devices
2. Skills- India regulatory affairs submission, good in Manufacturing licensing, added advantage having experience in windchill.
3. Education - Bachelor's degree in engineering
4. Anything else-
Regulatory Requirements
Global Regulations Monitoring
Regulatory Reporting
Recordkeeping
Research & Analysis
Regulatory Agency Liaison
Impact Evaluation
Strategy Implementation
Business Acumen
Compliance Management Systems
Regulatory Advocacy
Knowledge Management
Communication Management
Market Intelligence
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
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.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.