Regulatory Affairs Specialist

Job Title

Job Description

Job Title : Regulatory Affairs Specialist

Job Responsibilities:
• Monitors global regulatory changes, interprets requirements, and integrates findings into regulatory strategies, ensuring timely communication with teams.
• Implements regulatory strategies for international markets, collaborating with cross-functional teams to align plans with organizational objectives and ensure compliance.
• Manages product registration and commercialization processes, preparing and submitting regulatory documents, coordinating with regulatory bodies, and ensuring accuracy and timeliness.
• Reviews regulatory documentation, validates marketing materials, and ensures compliance with local regulations for new product introductions.
• Builds and maintains strong relationships with regulatory agencies, industry organizations, and key stakeholders through regular communication and participation in forums.
• Tracks regulatory changes across regions, assesses their impact on the organization, and provides strategic recommendations to senior leadership.
• Collaborates with Post Market Surveillance to resolve escalated regulatory issues and ensure regional compliance.
• Prepares for regulatory audits, gathers required documentation, and supports responses to regulatory agencies, ensuring audit readiness.
• Identifies opportunities to optimize regulatory processes and drive continuous improvement initiatives for efficiency and compliance.
• Supports the development and maintenance of Quality Management System (QMS) documents and ensures adherence to regulatory requirements.
• Assists in preparing worldwide submissions for new products, ensuring compliance with regulatory standards and timely market release.
• Implements comprehensive labeling and safety plans, ensuring products meet regulatory standards and addressing safety issues as they arise.
• Uses lean tools and continuous improvement methodologies to address regulatory challenges, driving operational efficiency.
• Builds cross-functional relationships, communicates complex regulatory information clearly, and ensures alignment with regulatory standards.
• Analyzes the impact of regulatory changes, providing proactive insights and recommendations to inform strategic decision-making and policy development.

Minimum required Education:
Bachelor's Degree in Business Administration, Communications, Quality Management, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.

Minimum required Experience:
Minimum 2 years of experience in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Product Development, Supply Chain, Continuous Improvement, Quality Management or equivalent

Preferred Education:
Master's Degree in Business Administration, Legal, Communications, Science or equivalent

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
• Impact Evaluation
• Strategy Implementation
• Business Acumen
• Document Auditing
• Product Registrations
• Stakeholder Management
• Regulatory Submission Documentation
• Conformity Assessment
• 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.