Regulatory Affairs Specialist

We are looking for Regulatory Affairs Specialist for our client in Sunnyvale, CA

Job Title: Regulatory Affairs Specialist

Job Location: Sunnyvale, CA

Job Type: Contract

Job Overview:

Pay Range: $55hr - $60hr

Requirement/Must Have:

• 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 requirement.
• Ability to work in a fast-paced environment and handle multiple projects simultaneously.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Ability to communicate effectively with stakeholders.

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.

Nice to Have:

• RAPS Regulatory Affairs Certification (RAC) is a plus.

Skills:

• 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.

Qualification And Education:

• 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.