Regulatory Affairs Associate - Medical Device Labeling

Job Description

Job Description

Regulatory Affairs Associate – Medical Device Labeling

Job ID: ABOJP00048695
Location: Santa Clara, CA
Industry: Medical Devices / Cardiovascular
Employment Type: Contract
Contract Duration: November 30, 2026 – November 29, 2027
Company: Viltis

Position Overview

Viltis is seeking an experienced Regulatory Affairs Associate – Medical Device Labeling to support a leading global medical device manufacturer in Santa Clara, California.

This position will play a key role in developing and implementing international regulatory labeling for cardiovascular medical devices. The successful candidate will support the centralization of post-approval labeling activities across a diverse medical device portfolio, ensuring compliance with international regulatory requirements.

The ideal candidate will have a strong background in regulatory affairs, medical device labeling, documentation control, and cross-functional project coordination. This role requires an independent, detail-oriented professional capable of managing multiple labeling projects and navigating complex international regulatory requirements.

Key Responsibilities

Regulatory Labeling Development

• Develop and implement international addendum labeling, including Instructions for Use (IFUs), product labels, import labels, and country-specific labeling.
• Collaborate with Regulatory Affairs specialists, international regulatory affiliates, and labeling project managers to develop compliant labeling strategies.
• Ensure labeling meets applicable FDA requirements, international regulations, country-of-origin requirements, and certification standards.
• Evaluate labeling change requests and assess their regulatory impact.
• Manage multiple labeling projects, priorities, and deadlines independently.
• Coordinate with cross-functional teams to ensure labeling accuracy, consistency, and regulatory compliance.

Labeling Implementation and Change Control

• Prepare labeling documentation, coordinate redline reviews, and submit labeling packages for development and approval.
• Coordinate labeling releases with Regulatory Affairs, international affiliates, and Packaging, Labeling, and Program Management teams.
• Prepare and submit Universal Addendum Labeling (UAL) packages through SAP.
• Troubleshoot labeling implementation issues, identify risks, and develop effective solutions.
• Support process improvements and change management initiatives.

Regulatory Compliance and Intelligence

• Monitor evolving international medical device labeling regulations and regulatory trends.
• Translate regulatory changes into internal labeling requirements and quality system processes.
• Ensure labeling activities comply with established quality management procedures and applicable regulatory standards.
• Identify opportunities to improve regulatory labeling workflows and documentation processes.

Documentation and Reporting

• Maintain accurate labeling change records, approvals, and supporting documentation.
• Track labeling change requests across multiple projects.
• Prepare documentation and supporting materials for regulatory and quality audits.
• Support the development of KPI dashboards and regulatory performance metrics.
• Maintain organized, audit-ready regulatory records.

Required Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
• Minimum 4 years of experience in a regulated industry, including regulatory affairs, quality assurance, quality engineering, document control, regulatory compliance, or related operations.
• Demonstrated experience developing or managing product labeling from a regulatory perspective.
• Strong understanding of medical device labeling regulations and documentation requirements.
• Experience with document control, change management, and quality management systems.
• Proficiency with SAP MD or related enterprise systems.
• Strong Microsoft Office skills, particularly Excel, Word, and PowerPoint.
• Excellent written and verbal communication skills.
• Strong organizational, analytical, and problem-solving abilities.
• Ability to manage multiple projects independently and meet competing deadlines.

Preferred Qualifications

• Previous experience with medical device manufacturers, particularly cardiovascular or vascular devices.
• Experience with international medical device labeling requirements.
• Familiarity with FDA labeling requirements and international regulatory frameworks.
• Hands-on experience creating or updating Instructions for Use (IFUs), import labels, and country-specific labeling.
• Experience with SAP, Adobe Acrobat Pro, and electronic document management systems.
• Experience supporting regulatory change control and quality system improvements.
• Demonstrated success coordinating complex projects across Regulatory Affairs, Quality, Engineering, and Manufacturing teams.

Ideal Candidate Profile

The ideal candidate is a Regulatory Affairs or Regulatory Operations professional with direct experience managing medical device labeling activities in a highly regulated environment.

Successful candidates will demonstrate:

• Strong attention to detail and regulatory accuracy.
• Ability to work independently with minimal supervision.
• Experience collaborating with international regulatory stakeholders.
• Excellent project management and prioritization skills.
• Strong troubleshooting and critical-thinking capabilities.
• Ability to drive complex issues through resolution.
• Experience managing multiple concurrent labeling and documentation projects.

Why Join Viltis?

Viltis connects talented professionals with opportunities supporting innovative organizations across the medical device, biotechnology, pharmaceutical, and life sciences industries.

This opportunity offers exposure to international regulatory operations, medical device labeling, and cross-functional collaboration within a leading cardiovascular medical device organization.

How to Apply

Interested candidates are encouraged to apply with an updated resume highlighting relevant regulatory affairs, medical device labeling, SAP, and international regulatory compliance experience.

Viltis is an Equal Opportunity Employer. We consider qualified applicants without regard to legally protected characteristics.