Senior Regulatory Affairs Specialist (Medical Devices)

Location: Alameda, California, United States; onsite

Company

hirify.global provides consulting and workforce solutions to pharmaceutical, biotechnology, medical device, and life sciences organizations across regulatory, quality, clinical, engineering, and scientific functions.

What you will do

• Perform and document regulatory change assessments for medical devices, manufacturing processes, product modifications, labeling, and technical changes.
• Support the preparation, review, and management of U.S. medical device regulatory submissions.
• Support new product approvals, marketed-product compliance, market authorization, and product lifecycle management.
• Represent Regulatory Affairs on cross-functional teams and provide guidance to Quality, Engineering, Manufacturing, R&D, Product Development, and Marketing.
• Develop and implement regulatory strategies, interpret applicable regulations and guidance, and monitor emerging requirements.
• Participate in risk management and continuous improvement while maintaining clear, accurate, and audit-ready regulatory documentation.

Requirements

• 7+ years of medical device Regulatory Affairs experience required.
• Hands-on experience conducting regulatory change assessments.
• Strong knowledge of U.S. medical device regulatory requirements and submissions.
• Experience supporting commercially marketed medical devices and product lifecycle activities.
• Ability to interpret regulatory requirements and assess their impact on products, manufacturing, labeling, and technical changes.
• Strong communication, organizational, and deadline-management skills, with experience working cross-functionally.

Nice to have

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

Culture & Benefits

• Full-time schedule of 40 hours per week.
• Contract employment supporting a leading medical device organization.
• Cross-functional collaboration across regulatory, quality, engineering, manufacturing, research and development, and marketing functions.