- Title: Labeling Manager
- Code: RCI-01051
- Location: Bridgewater New Jersey (NJ) 08807
- Posted Date: 05/29/2020
- Duration: 6 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
• The role will work collaboratively with cross-functional representatives to gather feedback on new processes to ensure alignment on corporate procedures.
• Develop procedures for device labeling such as review process across matrix organization.
• Ensures all corporate procedures impacted by the new medical device labeling procedures are identified, assessed for updates, changes needed and that these changes are completed as appropriate
• Works with the Information Services (IS) team to identify changes needed into the systems to support new requirements.
• Lead Labeling Reviewer of Labeling for Devices (core label, US, EU).
• Lead Labeling Working Group of SMEs in review of labeling documents.
• Apply knowledge of Device regulations including, UDI and EUDAMED in compliance with all key internal and external global regulatory requirements including EU Medical Device Regulation (MDR).
• Represent or lead the RA Labeling function on assigned cross-functional project teams and projects to develop global device labeling requirements and labeling content.
• Monitor applicable global regulatory and labeling requirements; assure compliance with and external standards and help drive implementation across functions and projects.
• Effectively assess impact of emerging global labeling regulations and requirements for medical devices and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
• Effectively perform labeling gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications.
• Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key EU MDR labeling strategies and initiatives.
Extensive knowledge of medical device regulatory requirements for the US and EU MDR (Medical Device Regulation), and other global Device Labeling requirements Current knowledge of relevant US and International Regulations (including but not limited to); FDA QSR (21CFR 820,), ISO Requirements, GMP, and ability stay abreast of regulations pertinent to medical devices, and combination products.
• Practical knowledge of Project Management including experience managing complex projects with cross-functional teams.
• Knowledge of labeling workflow from creation to obsolescence; Prior experience in team management in a matrix organization.
Education / Experience
Minimum Bachelor’s degree (BA) Scientific, Regulatory or related field. Minimum three years direct experience in an FDA or EU Regulated environment a must, preferably with respect to the release of labeling and UDI. Experience with EU MDR a plus.