Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA

Must be able to work on a W2

Position: Regulatory Affairs Specialist

Employment Type: Contract

Years Experience: 2-5 years of regulatory experience and/or 2 years of relevant industrial experience, typically within a quality, product development/support, or scientific affairs function.

Skills Required:

• Knowledge of regulations and standards affecting In Vitro Diagnostics (IVDs) and/or biologics.
• Experience with Japanese and Chinese regulatory submissions
• Ability to interpret and apply regulatory requirements.
• Strong communication and interpersonal skills.
• Detail-oriented with excellent organizational abilities.
• Proficiency in Microsoft Office suite.

Education: Bachelor's degree preferred in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, or related field.

Duties and Responsibilities:

• Implement and maintain the effectiveness of the quality system.
• Support day-to-day manufacturing and operations activities related to change control.
• Provide consultation and advice to regulatory specialists regarding change control and product development.
• Offer regulatory direction and interpretation on team activities.
• Apply regulatory knowledge to support product-related activities.
• Prepare U.S. regulatory submissions and registration documents for international affiliates and government agencies worldwide.
• Manage regulatory activities related to documentation, labeling, and field support.
• Apply regulatory and technical knowledge to complex work assignments.
• Ensure compliance with the appropriate quality system for supported medical devices.
• Maintain and demonstrate knowledge of site and division-level policies and procedures.

Additional Requirements:

• Collaborate effectively with cross-functional teams.
• Stay informed about changes in regulations and standards affecting medical devices.
• Participate in audits and inspections as needed.
• Contribute to continuous improvement initiatives within the regulatory affairs function.
• Ability to prioritize tasks and manage multiple projects simultaneously.