Global Medical Device Labeling Specialist (Contract)

TalentBurst, an Inc 5000 company; Santa Clara (CA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

TalentBurst is seeking a highly skilled Regulatory Affairs Operations Specialist to join our Regulatory Affairs Operations team in Santa Clara. The role focuses on designing and implementing international addendum labeling (IFUs, import labels, country-specific labeling) for our medical device portfolio, coordinating with global RA experts and US product owners.

You will manage large-scale labeling change projects, ensure compliance with FDA and international requirements, and drive

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.
• Experience working with policies and procedures impacting documentation and documentation practices.
• Proven experience in labeling design and development from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.
• Proficiency in SAP MD and other relevant software systems.
• Excellent communication and collaboration skills.
• Detail-oriented with strong organizational skills.
• Good people relations, able to work independently with good administrative and time management skills.

Responsabilités

• Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project management to develop labeling strategies.
• Create and design addendum labeling including Instructions for Use (IFUs), product labels, import labels, and country-specific labeling.
• Fulfill international addendum labeling requests, ensuring conformance with international country requirements, country of origin, and international certification marks.
• Ensure all labeling complies with regulatory requirements and standards.
• Effectively work with cross-functional team to develop labeling that meets the requirements of the FDA and international regulatory agencies, internal brand/design requirements, and product specifications.
• Independently manage large-scale labeling change projects.
• Communicate labeling projects and priorities across the division, plan project timelines which may involve managing multiple, concurrent deadlines.
• Complete assessments for projects to identify scope and impact to labeling.
• Understand impact of changing regulations and product requirements regarding labeling.
• Fill out forms, coordinate redlines review and submit labeling packages to the labeling team for development.
• Coordinate labeling release with Regulatory Affairs specialists, international regulatory affiliates, and the Packaging, Labeling, and Program Management (PLPM) team.
• Prepare and submit Universal Addendum Labeling (UAL) SAP package to PLPM team to program addendum labeling.
• Troubleshoot issues, communicate impact, and propose solutions.
• Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
• Ensure all labeling activities comply with internal procedures and regulatory requirements.
• Stay updated on changes in regulatory requirements and implement necessary updates to internal procedures.
• Driving quality system process improvement initiatives (e.g. change management).
• Maintain accurate records of labeling changes and approvals.
• Track labeling change requests for multiple projects.
• Provide documentation and support for audits.
• Driving preparation of KPI dashboards and maintaining a pulse on formal RA internal metrics.

Connaissances

Troubleshooting

Critical thinking

Problem resolution

Multitasking

Formation

Bachelor's degree in Regulatory Affairs

Outils

SAP MD

Adobe Acrobat Pro

Description du poste

TalentBurst is seeking a highly skilled Regulatory Affairs Operations Specialist to join our Regulatory Affairs Operations team in Santa Clara. The role focuses on designing and implementing international addendum labeling (IFUs, import labels, country-specific labeling) for our medical device portfolio, coordinating with global RA experts and US product owners.

You will manage large-scale labeling change projects, ensure compliance with FDA and international requirements, and drive