Position Title: Regulatory Affairs Associate
Work Location: Santa Clara, California, USA 95054
Assignment Duration: 12 Months

Position Summary: Seeking a highly skilled Regulatory Affairs Operations Specialist to design, develop, and implement international addendum labeling for medical devices, meeting international requirements.

Background & Context:
This role will introduce a new process to centralize post-approval addendum labeling activities for the full vascular medical device portfolio.

Key Responsibilities:

• 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.

Qualification & Experience:

• 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.
• PC and Microsoft Office experience.
• Experience with medical device labeling or labeling for highly regulated industry and international regulatory requirements (preferred).
• Familiarity with Adobe Acrobat Pro, SAP, and other content management systems (preferred).
• Substantial experience coordinating and executing project activities in a highly regulated industry (preferred).

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.