Regulatory Affairs Associate

Title: Regulatory Affairs Associate

Location: Santa Clara, CA

Duration: 12 Month

100% Onsite

Description / Summary

We are seeking a highly skilled and experienced Regulatory Affairs Operations Specialist to join our Regulatory Affairs Operations team. The position will be responsible for designing, developing, and implementing international addendum labeling (IFUs, import labels, country-specific labeling) that meets international requirements for our medical devices. This role requires background in regulatory affairs and experience with labeling from a regulatory perspective. The individual will be responsible for liaising with international RA local experts and US RA product owners as key stakeholders.

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. PC and Microsoft Office experience.
  
  

Preferred Qualifications

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

Key Responsibilities

This role will introduce a new process to centralize post-approval addendum labeling activities for the full Abbott Vascular medical device portfolio.

Label Design And Development

• 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.
  
  

Labeling Implementation

• 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.
  
  

Regulatory Affairs / Regulatory Intelligence

• 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).
  
  

Documentation And Reporting

• 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.
  
  

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)
  
  

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.