Director, Regulatory Affairs & Operations (North America)

Director, Regulatory Affairs & Operations (North America)

Hybrid at Location: Valencia, CA 91355

Compensation: $156-$205,000 (Direct Hire)

Position Type: Direct Hire

Overview

We are seeking an experienced and strategic Director of Regulatory Affairs and Operations to lead a dynamic team and navigate the regulatory landscape for Class III medical devices. This critical role will be responsible for ensuring regulatory compliance throughout the full product lifecycle, driving product approvals, and collaborating cross-functionally to align regulatory strategies with business objectives. If you're passionate about regulatory innovation and have experience leading global submissions in diverse markets such as the US, EU, China, and Latin America, this opportunity is for you.

Key Responsibilities

• Lead Regulatory Strategy: Develop and implement regulatory strategies for Class III medical devices, focusing on product approval and market access in North America, with global expansion opportunities (including EU, China, Latin America, and Switzerland).
• Drive Regulatory Innovation: Bring a strategic mindset to the role, leading initiatives to improve and innovate regulatory processes and contribute to the development of new approaches to regulatory challenges.
• Regulatory Submissions & Approvals: Lead all regulatory submissions, including FDA, EU MDR, and other global regulatory filings, ensuring timely product approvals across regions.
• Product Life Cycle Management: Oversee regulatory compliance across the full product development lifecycle, from early product development to post-market activities, ensuring all aspects meet regulatory standards.
• Team Leadership & Development: Manage and mentor a high-performing team of 6 direct reports and 12 total reports. Foster a culture of accountability, continuous learning, and high performance.
• Risk Management & Labeling: Lead the development of risk management strategies and ensure compliance with global labeling standards for medical devices.
• Stakeholder Engagement: Act as the primary liaison with key regulatory authorities such as the FDA, Health Canada, Notified Bodies, and regulatory bodies in Latin America and China.
• Change Control Management: Develop and implement a Change Control Plan (PCCP) to ensure compliance and manage regulatory changes efficiently, especially in the context of recalls or product modifications.
• Cross-Functional Collaboration: Collaborate with R&D, QA, Marketing, and Manufacturing teams to align regulatory strategies with overall business goals and drive innovation.
• Market Awareness & Global Expansion: Support submissions and approvals in global markets such as the EU, Latin America, and China, and ensure alignment with local regulations.

Required Qualifications

• Experience: Minimum of 12 years of experience in regulatory affairs, including 8 years in a leadership role and experience with Class III medical devices.
• Regulatory Knowledge: Extensive knowledge of FDA, EU MDR, APAC, China, and Latin American regulations. Experience with global submissions and approvals is a must.
• Strategic Mindset: Ability to think strategically and bring innovation to regulatory processes, particularly in the context of product lifecycle management, regulatory submissions, and global market expansion.
• Product Lifecycle Experience: Strong understanding of the full product development lifecycle, including the ability to manage regulatory requirements at every stage—from early development to post-market surveillance.
• Change Control Experience: Familiarity with Change Control Plans (PCCP), particularly with handling device recalls and managing the regulatory aspects of product changes.
• Degree Requirements: A degree in Regulatory Affairs is not required; a scientific or technical background is preferred.
• Leadership & Collaboration: Proven ability to lead, mentor, and collaborate with cross-functional teams to achieve regulatory goals.
• Global Travel Flexibility: Ability to travel occasionally (up to 10%) for meetings with regulatory bodies and other stakeholders, with potential travel to Switzerland for key regulatory discussions.

Desired Skills & Competencies

• Regulatory Innovation: What does regulatory innovation look like to you? We’re looking for candidates with the ability to think creatively and introduce innovative regulatory solutions to complex challenges.
• Global Perspective: In-depth knowledge of regulatory environments in multiple global markets, particularly FDA, EU MDR, China, and Latin America.
• Resilience & Problem-Solving: Proven track record in managing regulatory challenges, particularly in the event of recalls or product lifecycle changes.
• Cross-Functional Leadership: Ability to influence stakeholders at all levels, from R&D to senior leadership, ensuring regulatory strategies are integrated seamlessly into product development plans.

Additional Details

• Travel Requirement: Occasional travel (up to 10%) to regulatory authorities, industry events, or cross-functional team meetings, with potential for international travel to Switzerland.
• Reports to: SVP, Global Quality Assurance and Regulatory Affairs