Senior Regulatory Affairs Specialist – Medical Devices

Senior Regulatory Affairs Specialist – Medical Devices
Clinical San Diego , California Contract Aug 10, 2026

Viltis is seeking an experienced Senior Regulatory Affairs Specialist to support a leading medical device organization in San Diego, CA.

The ideal candidate will bring at least 7 years of Medical Device Regulatory Affairs experience
, with particular expertise in regulatory change assessments and U.S. medical device submissions
.

This individual will serve as a regulatory subject matter expert and partner closely with cross-functional teams to support new product approvals, maintain regulatory compliance for marketed products, and evaluate product, manufacturing, labeling, and technical changes for regulatory impact.

• Perform and document regulatory change assessments for medical devices, manufacturing processes, product modifications, labeling changes, and other technical changes.
• Support the preparation, review, and management of U.S. medical device regulatory submissions
  .
• Help ensure timely regulatory approval of new medical devices and continued compliance and approval of marketed products.
• Serve as the Regulatory Affairs representative on cross-functional project teams
  .
• Provide regulatory guidance to product development, manufacturing, quality, engineering, and marketing teams.
• Assess manufacturing changes, product line extensions, technical documentation, and labeling for regulatory impact.
• Interpret applicable medical device regulations, guidance documents, and regulatory requirements.
• Participate in the development and implementation of regulatory strategies for new and existing products.
• Support product planning and lifecycle management activities from a regulatory perspective.
• Participate in risk management activities and ensure regulatory considerations are appropriately incorporated into project decisions.
• Monitor regulatory policy, intelligence, and emerging requirements that may impact products or business activities.
• Participate in continuous improvement initiatives related to regulatory processes and documentation.
• Maintain clear, accurate, and audit-ready regulatory documentation.

• 7+ years of Medical Device Regulatory Affairs experience required.
• Significant hands-on experience conducting regulatory change assessments
  .
• Strong working knowledge of U.S. medical device regulatory requirements and submissions
  .
• Experience supporting commercially marketed medical devices and product lifecycle activities.
• Demonstrated ability to interpret regulatory requirements and determine their impact on product, manufacturing, labeling, and technical changes.
• Experience working effectively with cross-functional teams including Quality, Engineering, Manufacturing, R&D, and Marketing.
• Strong written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple regulatory priorities and deadlines.

• Experience developing or contributing to medical device regulatory strategy.
• Experience supporting regulatory submissions and maintaining market authorization for existing products.
• Knowledge of medical device risk management principles.
• Experience supporting product line extensions, manufacturing changes, and labeling updates.
• Experience with in diabetes care, diagnostics, combination products, or other highly regulated medical device environments is a plus.

Viltis partners with leading pharmaceutical, biotechnology, medical device, and life sciences organizations to provide specialized consulting and workforce solutions across Regulatory Affairs, Quality, Clinical, Engineering, and Scientific functions.