Regulatory Affairs Global Regulations Specialist

Job Description

Job Title: Regulatory Affairs Global Regulations Specialist

Job Responsibilities:
u2022 Stays updated on global regulatory requirements by monitoring regulatory bodies, industry publications, and relevant sources, ensuring preparedness for regulatory changes.
u2022 Assists in implementing global regulatory strategy, collaborating with cross-functional teams, and drafting strategic documents aligned with business objectives.
u2022 Coordinates compliance with country-specific regulations for product registration, overseeing submission processes, ensuring accurate documentation, and working with regulatory agencies.
u2022 Builds and maintains relationships with regulatory agencies, attending industry events, and representing the organization in regulatory discussions.
u2022 Tracks and interprets changes in regulations across countries, analyzing implications and providing reports and recommendations to senior management.
u2022 Uses metrics and key performance indicators to evaluate and optimize the effectiveness of the Global Regulatory Affairs function.
u2022 Maintains global documentation for registration activities, updating databases with record information and supporting regulatory submissions.
u2022 Contributes to risk assessments related to international regulatory compliance and product safety, developing risk mitigation strategies.
u2022 Assists in regulatory assessments of product changes, ensuring compliance throughout the product lifecycle.
u2022 Prepares worldwide submissions for new products and changes, ensuring timely approval for market release while adhering to regulations and guidance.
u2022 Utilizes lean tools and continuous improvement methodologies to address regulatory challenges and enhance management practices.
u2022 Monitors regulatory databases, industry publications, and guidance documents to stay current on regulatory updates and emerging trends.
u2022 Supports the development of regulatory and standards policies, tracking regulatory activities and ensuring compliance readiness for audits and inspections.
u2022 Provides regulatory guidance during product development, collaborating with internal teams and external partners to integrate regulatory requirements.
u2022 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:
u2022 Regulatory Requirements
u2022 Global Regulations Monitoring
u2022 Data Management
u2022 Research & Analysis
u2022 Regulatory Agency Liaison
u2022 Strategy Implementation
u2022 Document Auditing
u2022 Product Registrations
u2022 Product Labeling
u00B7 Continuous Improvement
u00B7 Regulatory Compliance Monitoring
u00B7 Data Analysis & Interpretation
u00B7 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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 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 youu2019re 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 .