Senior Regulatory Affairs Specialist - Medical Devices

Job Description

Job Description

Senior Regulatory Affairs Specialist – Medical Devices

Location: Alameda, CA
Schedule: Full-Time, 40 Hours/Week
Employment Type: Contract

Position Overview

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Experience

• 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 within diabetes care, diagnostics, combination products, or other highly regulated medical device environments is a plus.

About Viltis

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.

If you are an experienced Medical Device Regulatory Affairs professional with a strong background in regulatory change assessments and U.S. submissions, we encourage you to apply.