Job Description

Work Flexibility: Hybrid

What you will do: * Support management of labeling approval and release, coordinating labeling through project development cycles

• Possess and apply knowledge and understanding of the global regulatory labeling requirement. Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products.
• Review external standards for compliance assessment.
• Review labeling and marketing literature for compliance with regulatory requirements.
• Process and implement IFU related change requests, including management of approval processes and implementation.
• Assist in corporate oversight of labeling standards, requirements, data, technical solutions, business process, infrastructure, licenses, etc
• Subject Matter Expert within Stryker on the requirements of global labeling, electronic IFUs, content management systems, and translations
• Participate in managing the IFU/eifu system, including review of requirements and existing IFUs.
• Utilize and comply with Stryker\xe2\x80\x99s Quality Management System including proactively verifying if requirements are met and managing changes within the Quality System
• Drive coordination with different departments to ensure the resulting IFU/Collateral Material is compliant, and effective
• Review & approval co-ordination of non-labelling jobs. Contribute to the weekly released report & maintenance of artwork archives
• Publication and/or uploading of approved documents on global portals
• Translation coordination of technical documentations
• Supporting labelling & collateral supporting system for periodic updates & reports
• Print current labels for Regulatory Authority registration requests & Support with printing current/updated labels during mass changes
• Language Independent document formatting
• Represent Global Labeling as Local Project Coordinator on major projects
• Process and implement IFU/IFP-related change requests, including management of approval processes and implementation. Assist as required with Production IFU/IFP issues and problems.
• Participate in managing the IFU/IFP system, including review of requirements and existing IFPs/IFPs
• Utilize and comply with Stryker\xe2\x80\x99s Quality Management System including proactively verifying if requirements are met and managing changes within the Quality System
• Create & manipulate logotypes, symbols and other graphics for inclusion on IFUs/IFPs.
• Subject Matter Expert within Stryker on the requirements of electronic IFUs/IFPs, content management systems, and translations. - executive sponsors to user level.
• Assist in corporate oversight of labeling standards, requirements, data, technical solutions, business process, infrastructure, licenses, etc.
• Drive coordination with different departments to ensure the resulting IFU/Collateral Material is compliant, and effective.
• Initiate and maintain effective collaboration between the Technical Publications team and engineering groups

What you need:

• Educational background of bachelor\xe2\x80\x99s degree in Technical Writing or Technical Communications / Mechanical / Computer Science / Biomedical / English
• A minimum of 8 years of experience in an FDA regulated industry required.
• A minimum of 5 years of Regulatory Affairs experience required.
• Direct Medical Device Labeling experience
• 5 years\xe2\x80\x99 experience in designing, writing, and publishing technical documentation (labelling/technical publication/collateral materials)
• Excellent verbal and written communications focused on scientific or technical communications

Characterized by analytical and transdisciplinary reasoning, with a good attention to detail.

Travel Percentage: 10%

Stryker