Associate RA Manager

Job Title

Associate RA Manager

Job Description

Job Responsibilities:

• Contributes efforts to stay updated on global and regional regulatory requirements for products by establishing effective monitoring systems, and ensuring that all information is promptly and accurately communicated to relevant stakeholders and integrated into regulatory strategies.
• Executes global regulatory strategies for international markets by coordinating with cross-functional teams, aligning regulatory goals with business objectives, supporting the identification of regional regulatory requirements, and ensuring that all activities comply with both global standards and local regulations.
• Ensures strict compliance with country-specific regulations for product registration and commercialization by overseeing the submission process, ensuring that all documentation is thorough and accurate, maintaining local establishment registrations, and addressing any issues or discrepancies in a timely and effective manner.
• Cultivates strong working relationships with regulatory agencies by proactively engaging with key contacts, attending industry events, maintaining open lines of communication, and ensuring that the organization is well-represented in all regulatory interactions to facilitate smooth approvals and compliance.
• Leverages regulatory intelligence to improve global and regional regulatory processes by identifying data trends and insights that can be used to anticipate future regulatory changes, enhance existing policies and procedures, and support the continuous improvement of regulatory functions.
• Interprets and communicates changes in regulations across different countries by conducting thorough research, preparing detailed reports, providing actionable insights and recommendations to senior management, and updating regulatory strategies to remain compliant and competitive.
• Uses metrics and key performance indicators to assess and enhance the performance of the Global Regulatory Affairs function, enabling informed decision-making, action planning, and ongoing enhancements that align with the organization's regulatory and business objectives.
• Supports regulatory audits and inspections by meticulously preparing documentation, coordinating responses with internal stakeholders, and ensuring full compliance with both global and regional regulatory requirements throughout the audit process.
• Coordinates local testing required to support regulatory submissions, ensures that all necessary tests are conducted in compliance with local regulations, and collaborates with internal teams to ensure that testing data is accurately documented and submitted.
• 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, and contributes to maintaining compliance by providing necessary documentation and strategic insights.
• Contributes to the development and maintenance of Quality Management System (QMS) documents in compliance with regional requirements, ensuring that quality management support is consistently provided for the zone or region, and that all regulatory and quality processes are aligned with both global and local standards.

Minimum required Education:
Bachelor's Degree in Business Administration, Legal, Communications, Quality Management or equivalent/ Vocational Education.

Preferred Certification:
RAPS RAC certification.

Preferred Skills:
• Regulatory Requirements
• Global Regulations Monitoring
• Regulatory Reporting
• Data Management
• Recordkeeping
• Research & Analysis
• Regulatory Agency Liaison
• Impact Evaluation
• Strategy Implementation
• Business Acumen
• Communication Management
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.