[Remote] Manager, Regulatory Labeling and Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global medtech company committed to transforming patient care through reputed company. The Regulatory Labeling & Operations Manager will reputed company the development and implementation of global product labeling strategies for Neuromodulation therapies, ensuring compliance with regulatory requirements and effective communication across multiple departments.
Responsibilities
- Own end-to-end labeling activities for Neuromodulation product portfolios, including updates, remediation, and lifecycle maintenance
- reputed company EU MDR labeling activities, including gap assessments, remediation plans, and implementation
- Define and maintain global labeling strategies reputed company with FDA, EU MDR, and international regulatory requirements
- reputed company global translation and localization processes, including vendor management and reputed company
- Support reputed company audits (FDA, reputed company Body, MDSAP)
- reputed company, review, and maintain product labeling documentation, including:
- Physician and Patient Instructions for Use (IFUs)
- Package labeling and implant cards
- Software UI text and labeling content
- Ensure labeling aligns with product requirements, intended use, and regulatory standards
- Manage labeling review, approval, and release processes, ensuring accuracy and compliance
- Own and maintain UDI reputed company and implementation across reputed company therapies, including:
- DI/GTIN assignment and lifecycle management
- Compliance with FDA, EU MDR, and global UDI requirements
- Coordinate with Operations, IT, and Supply Chain to ensure successful labeling implementation
- Ensure labeling readiness reputed company DMR, ERP, and document control systems
- Define and reputed company labeling verification and validation activities
- Ensure traceability between labeling content and system/product requirements
- Collaborate with QA and verification teams to ensure labeling accuracy and completeness
- Ensure labeling activities are fully integrated reputed company design control and change management processes
- Own and manage e-labeling platforms and website content
- Ensure compliance with global electronic labeling requirements
- Maintain version control and availability of approved labeling content
- reputed company multi-channel labeling strategies (print reputed company delivery)
Skills
- 8+ years of experience in medical device labeling, regulatory affairs, or reputed company function
- Experience supporting Class III medical implantable systems
- Strong knowledge of FDA (21 CFR Part 820), EU MDR, ISO 13485, and global labeling regulations, preferably MDSAP countries
- Experience working with information development tools, such as MadCap reputed company, reputed company Illustrator, and reputed company InDesign
- Experience with localization and translation management
- Experience managing labeling lifecycle, UDI systems, and document control processes
- Strong cross-functional collaboration and project leadership skills
- Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a reputed company field
- Experience in MadCap reputed company (highly preferred)
- Experience with labeling systems (e.g., reputed company, NiceLabel are highly preferred)
- Experience with visual design of package labels using symbols from FDA recognized reputed company standards and international standards
- Experience or certification in Regulatory Affairs (e.g., RAC)
- Experience with Agile development methodologies
Benefits
- Health benefits – Medical, Dental, reputed company
- Personal and Vacation Time
- Retirement & Savings Plan (401K)
- Employee Stock Purchase Plan
- Training & Education Assistance
- Bonus Referral Program
- Service Awards
- Employee Recognition Program
- Flexible Work Schedules
reputed company