Regulatory Affairs Associate: Medical Device Labeling (Intl)

TechyPeople.Net; Santa Clara (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

TechyPeople.Net is seeking a Regulatory Affairs Associate in Santa Clara, CA to lead international addendum labeling for a medical device portfolio. You will develop IFUs, product labels, and country-specific labeling while ensuring compliance with FDA and international requirements.

The role requires 4+ years in a regulated industry, strong experience in labeling design from a regulatory perspective, and proficiency with SAP MD. You will work with global affiliates, U.S.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry (Regulatory Affairs, regulatory compliance, quality control, quality engineering, document control, or engineering).
• Proven experience with labeling design and development from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.
• Experience working with controlled documentation, policies, and procedures.
• Proficiency with SAP MD and relevant software systems.
• Strong communication, collaboration, organizational, and time-management skills.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency with Microsoft Office.

Responsibilities

• Develop and implement international addendum labeling, including IFUs, product labels, import labels, and country-specific labeling.
• Collaborate with Regulatory Affairs specialists, international regulatory affiliates, labeling project management, and U.S. product owners to develop labeling strategies.
• Ensure labeling complies with FDA, international regulatory, country-of-origin, certification mark, and product requirements.
• Independently manage labeling change projects and coordinate multiple concurrent timelines and priorities.
• Assess regulatory and product changes to determine their impact on labeling.
• Coordinate redline reviews, labeling packages, implementation, and labeling releases.
• Prepare and submit Universal Addendum Labeling (UAL) SAP packages.
• Monitor emerging international regulatory requirements and translate changes into applicable processes and quality systems.
• Maintain accurate records of labeling changes, approvals, and project status.
• Support regulatory audits and quality system/process improvement initiatives.
• Track multiple labeling change requests and support preparation of Regulatory Affairs KPI dashboards.
• Troubleshoot labeling and regulatory issues, assess their impact, and drive solutions through resolution.

Skills

Regulatory Affairs & Compliance

Medical Device Labeling

IFUs & International Labeling

Regulatory Documentation

SAP

Project Coordination

Troubleshooting & Critical Thinking

Cross-functional Collaboration

Multitasking / Prioritization

Education

Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or related field

Tools

SAP MD

Content management systems

Job description

TechyPeople.Net is seeking a Regulatory Affairs Associate in Santa Clara, CA to lead international addendum labeling for a medical device portfolio. You will develop IFUs, product labels, and country-specific labeling while ensuring compliance with FDA and international requirements.

The role requires 4+ years in a regulated industry, strong experience in labeling design from a regulatory perspective, and proficiency with SAP MD. You will work with global affiliates, U.S.