Job Description

Director, Regulatory Affairs – Regulatory Operations and North America

Location: Valencia, CA (Hybrid: 3 days onsite, 2 days remote)

Industry: Medical Devices (Class III Active Implantables)

Pay Rate: Up to $205,000/year

Schedule: Monday – Friday, Standard Day Hours

Travel: Up to 10%

Overview:

Kelly® Science & Clinical is seeking a Director, Regulatory Affairs for a direct hire position at a leading medical device client in Valencia, CA. This is a hybrid role offering a unique opportunity to lead regulatory strategy and operations for advanced Class III medical devices in North America. If you are passionate about advancing science and ready to take the next step in your career, trust The Experts at Hiring Experts.

Key Responsibilities:

Regulatory Strategy & Submissions:

• Develop and implement comprehensive regulatory strategies for Class III devices in the U.S. and Canada
• Lead preparation, submission, and maintenance of regulatory filings including IDEs and other clinical study support documentation
• Ensure timely product approvals by aligning strategies with business and regulatory requirements

Compliance & Risk Management:

• Ensure product lifecycle compliance with global regulatory standards (FDA, EU MDR, Health Canada, etc.)
• Proactively assess regulatory risks and lead mitigation and inspection readiness initiatives
• Oversee field corrective actions and agency communications

Team Leadership & Development:

• Lead, mentor, and develop a high-performing regulatory affairs team
• Guide RA team members embedded in cross-functional product development teams
• Drive performance management, professional development, and ensure adherence to employment regulations

Cross-Functional Collaboration:

• Partner closely with R&D, Quality Assurance, Marketing, and Manufacturing to align regulatory objectives
• Provide regulatory input on design changes and lifecycle management initiatives

Labeling & Regulatory Framework:

• Oversee labeling processes to meet global standards and country-specific requirements
• Lead integration of evolving external standards and regulatory changes across the organization

Budget & Strategy:

• Contribute to RA budget planning, forecasting resource needs, and managing submission costs
• Track financial performance against regulatory strategic initiatives

Qualifications:

Education:

• Bachelor’s degree in Regulatory Affairs or a scientific discipline required
• Advanced degree or RAC certification preferred

Experience:

• 12+ years in international regulatory affairs (both submissions and compliance)
• 8+ years of progressive management experience
• 5+ years working in a Class III medical device company
• Proven experience in cross-functional matrix environments
• Experience with battery-operated electromechanical systems and/or wireless tech is highly desirable
• Experience managing global, remote teams

Key Competencies:

Leadership:

• Strong mentorship, strategic thinking, and ability to lead across all levels
• Proven ability to deliver results, navigate change, and drive performance

Communication:

• Clear, concise, and persuasive communication with regulatory authorities and stakeholders

Collaboration & Influence:

• Builds trusted partnerships across teams to achieve shared goals
• Influences effectively while maintaining professionalism and accountability

Professionalism & Problem Solving:

• Manages complex issues, prioritizes effectively, and fosters a culture of compliance and excellence

Additional Requirements:

• Must be legally authorized to work in the U.S. without sponsorship

Next Steps:

Apply now for immediate consideration. If you’re a strong match, you’ll hear from us shortly. If not, you’ll still remain in our talent network for future opportunities with our expert Science & Clinical recruitment team.

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