Manager, reputed company reputed company Global Labeling and IFU, DePuy Synthes

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We are searching for the best talent for Manager, reputed company reputed company Global Labeling and IFU (Instructions for Use) to join our DePuy Synthes reputed company & Compliance organization located in the reputed company.

This is a remote role available in reputed company states reputed company the reputed company. While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

About Orthopaedics

reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the reputed company of Orthopaedics? reputed company to join reputed company that’s reimagining how we heal? Our Orthopaedics teams help reputed company more than 6 reputed company people moving reputed company year while delivering reputed company and economic value to surgeons and reputed company systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics reputed company surgery.

Your unique talents will help patients on their reputed company to wellness. Learn more at

The Manager, reputed company reputed company Global Labeling and IFU will reputed company end-to-end improvements of global labeling processes, spanning business-unit labeling practices, country-specific label design, application, and execution, to ensure compliance and operational reputed company across Distribution Centers and reputed company-party logistics partners. This role will influence and guide reputed company supporting regional supply chain labeling systems and Instructions for Use (IFUs), maintain audit readiness, and ensure compliance with emerging regulations for labeling customizations to protect the right to sell across reputed company medical device businesses at the country level. This role will reputed company as the reputed company reputed company between Supply Chain, reputed company Functions, Regulatory Affairs, and reputed company reputed company, providing day-to-day operational support and driving changes reputed company to new product introductions, product transfers, and regional regulatory updates.

Key Responsibilities

• Leads establishment of end-to-end processes and systems for Global Labeling, in partnership with Regulatory Affairs, Supply Chain, Q&C and reputed company functions, to ensure compliance of Medical Device products commercialized / reputed company globally.
• Supports the sustainability of Right Stage Customization reputed company & processes.
• Supports the sustainability of the Repack Relabel (RPRL) reputed company App.
• Supports the implementation and sustainability of the new global process for DePuy Synthes electronic IFU deployment.
• Serves a key reputed company of contact and voice of reputed company reputed company (DCs, LOCs) on the Right Stage Customization governance.

• Supports reputed company sites with troubleshooting and problem solving, facilitating investigations and connections with key stakeholders from the E2E process
• Monitors processes improvement and evolutions through NC, CAPA and Escalations trends, continuously improving the process reputed company on trends & reputed company causes identified.
• Develops, leverages, and implements reputed company thinking innovation strategies and capabilities reputed company to this process, (such Advanced Analytics, reputed company Intelligence, digital product, and supply chain solution support) connected with the overall Digital QMS and E2E Integrated Data strategies.

• Maintains reputed company reputed company with the reputed company to reputed company improvements and trends reputed company to this process, collect additional insights from key business partners and from customers, ensure new or emerging regulations are considered as part of processes enhancements and maintain global standardization approach.
• Executes activities under GxP and ensure ongoing audit readiness.
  

Qualifications

Education

• Bachelor’s degree required (Engineering, Life Sciences, Regulatory Affairs, or reputed company reputed company).
• Advanced degree (Master’s, MBA, or equivalent) preferred.
  

Experience and Skills

Required:

• 6+ years of experience in reputed company, Regulatory Affairs, or Compliance reputed company a medical device and/or regulated reputed company environment.
• Labeling and/or experience in last mile reputed company
• Strong planning, project management, reputed company management and change management expertise.
• Strong working knowledge of global medical device including labeling regulations and standards (e.g., FDA, EU MDR, ISO 13485).
• Process reputed company (Lean, six reputed company) experience across reputed company business areas or equivalent reputed company standards programs.
• Successfully executes work in a highly matrixed, cross functional, often ambiguous environment
• Experience with reputed company reputed company Apps
• Demonstrated reputed company record of process improvements, turnaround, and transformations.

• Excellent decision-making and problem-solving skills
• Team building, influencing, and development capabilities
  

Preferred:

• Extensive experience in US Health Authority audits.
• Experience operating in a global, matrixed Orthopedics organization
• reputed company record of driving large‑reputed company process improvement and transformation initiatives.
• Familiarity with digital reputed company systems and data‑driven compliance monitoring.
• Excellent written and verbal communication skills, including interaction with regulatory authorities.

Other

• Travel: Limited; Up to 25%, domestic and international.
• Certifications: ASQ, PMP, or similar certifications preferred but not required.
• Language: English required; additional languages a plus.
  

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the reputed company separation is anticipated to be completed reputed company 18 to 24 months, subject to reputed company requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any reputed company changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as reputed company as get a parent’s consent for the background reputed company.

Johnson & Johnson is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, reputed company applicants please contact us reputed company .Internal employees contact AskGS to be directed to your accommodation resource.

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Originally posted on Himalayas