Director, Regulatory Affairs

$156,000 - $234,000/Yr

Sonova USA - Santa Clarita, CA

Full-time - Senior

Hybrid - Santa Clarita, CA

Merchant Wholesalers, Nondurable Goods

About the position

The Director of Regulatory Affairs at Sonova plays a critical leadership role in guiding the regulatory team to navigate complex regulatory landscapes and ensure compliance with all applicable regulations for active implantable medical devices. This position involves developing and implementing regulatory strategies, overseeing compliance, managing submissions and approvals, and leading a team of regulatory professionals. The role requires collaboration with cross-functional teams and acting as a liaison with regulatory authorities to ensure successful product approvals and compliance throughout the product lifecycle.

Responsibilities

• Develop and implement comprehensive regulatory strategies for Class III medical devices in the US and Canada.
• Ensure compliance with regulatory standards (FDA, EU MDR, and other international regulations) throughout the product lifecycle.
• Lead the preparation, submission, and maintenance of regulatory filings for the US and Canada.
• Manage and mentor a team of regulatory professionals, fostering professional growth and promoting a high-performance culture.
• Collaborate with R&D, Quality Assurance, Marketing, and Manufacturing teams to align regulatory strategies with business objectives.
• Develop risk mitigation strategies related to regulatory compliance, audits, and product approvals.
• Act as the primary liaison with regulatory authorities, managing relationships and communications with agencies such as the FDA and Health Canada.

Requirements

• Bachelor's Degree in Regulatory Affairs or a scientific discipline.
• Minimum of 12 years of experience in international regulatory affairs (both submissions and compliance).
• 8+ years of progressive management experience.
• 5+ years of experience working with business stakeholders within a cross-functional matrix environment.
• 5+ years of experience in a Class III Medical Device Company in Regulatory Affairs.

Nice-to-haves

• Advanced Degree in Regulatory Affairs.
• Further Education RA certification (by Regulatory Affairs Professional Society).
• Experience with full product lifecycle and understanding of development lifecycle and various technology methodologies.
• Desirable industry background includes battery-operated electromechanical systems and/or wireless technology.

Benefits

• Paid parental leave
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Tuition reimbursement
• Paid time off
• Employee assistance program
• Vision insurance
• 401(k) matching