Associate RA Manager
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Associate RA ManagerJob 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 organizations 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:
Bachelors 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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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 youre 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.
Required Experience:
Manager
Key Skills
- Restaurant Experience
- Fashion Retail
- Customer Service
- Hospitality Experience
- Store Management Experience
- Assistant Manager Experience
- Management Experience
- Retail Sales
- Leadership Experience
- Supervising Experience
- Restaurant Management
- Retail Management
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
