Regulatory Affairs Global Regulations Specialist

Job Title

Job Description

Job Title: Regulatory Affairs Global Regulations 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 2-3 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 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

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.
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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 .