Regulatory Affairs Specialist IV

Job Title: Regulatory Affairs Specialist IV
Location: Sunnyvale, California
Type: 6 month contract
Compensation: $55-60/hour depending on qualifications
Work Model: Hybrid – 3 days onsite
Hours: 40.0

Overview
Lead regulatory strategy and submissions for medical devices, supporting product development, design changes, lifecycle management, and regulatory approvals across the U.S., Canada, and global markets.

Responsibilities
• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
• Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, pre-submissions, Health Canada submissions with minimal supervision.
• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.

Requirements
• Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science).
• In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR.
• Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirements.
• Ability to work in a fast-paced environment and handle multiple projects simultaneously.
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
• Team player who seeks to help and learn from colleagues seeing the department success as their own.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism.
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.
• RAPS Regulatory Affairs Certification (RAC) is a plus.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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