Regulatory Affairs Business Specialist

Job Title : Regulatory Affairs Business Specialist

Job Responsibilities:
• Stays updated on global regulatory requirements by monitoring regulatory bodies, industry publications, and relevant sources, ensuring preparedness for regulatory changes.
• Assists in implementing global regulatory strategy, collaborating with cross-functional teams, and drafting strategic documents aligned with business objectives.
• Coordinates compliance with country-specific regulations for product registration, overseeing submission processes, ensuring accurate documentation, and working with regulatory agencies.
• Builds and maintains relationships with regulatory agencies, attending industry events, and representing the organization in regulatory discussions.
• Tracks and interprets changes in regulations across countries, analyzing implications and providing reports and recommendations to senior management.
• Uses metrics and key performance indicators to evaluate and optimize the effectiveness of the Global Regulatory Affairs function.
• Maintains global documentation for registration activities, updating databases with record information and supporting regulatory submissions.
• Contributes to risk assessments related to international regulatory compliance and product safety, developing risk mitigation strategies.
• Assists in regulatory assessments of product changes, ensuring compliance throughout the product lifecycle.
• Prepares worldwide submissions for new products and changes, ensuring timely approval for market release while adhering to regulations and guidance.
• Utilizes lean tools and continuous improvement methodologies to address regulatory challenges and enhance management practices.
• Monitors regulatory databases, industry publications, and guidance documents to stay current on regulatory updates and emerging trends.
• Supports the development of regulatory and standards policies, tracking regulatory activities and ensuring compliance readiness for audits and inspections.
• Provides regulatory guidance during product development, collaborating with internal teams and external partners to integrate regulatory requirements.
• Communicates complex regulatory information effectively to stakeholders and maintains detailed records for compliance and audit purposes.
Minimum required Education:
Bachelor's Degree in Business Administration, Legal, Communications, Quality Management or equivalent.
Minimum required Experience:
Minimum 4 years of experience in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Product Development, Supply Chain, Quality Management or equivalent
Preferred Education:
Master's Degree in Business Administration, Legal, Communications, Science or equivalent
Preferred Experience:
N/A
Preferred Certification:
RAPS RAC certification
Certified Associate in Project Management (CAPM)
Six Sigma
Certified Change Management Professional (CCMP)
Transformation-related certification or equivalent
Preferred Skills:
• Regulatory Requirements
• Global Regulations Monitoring
• Data Management
• Research & Analysis
• Regulatory Agency Liaison
• Strategy Implementation
• Document Auditing
• Product Registrations
• Product Labeling
· Continuous Improvement
· Regulatory Compliance Monitoring
· Data Analysis & Interpretation
· Operational Excellence Tools

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

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 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.