Valencia (CA), United States
VP Global Legal Affairs CI
The VP, Global Legal Affairs CI (Cochlear Implants) leads, manages and develops the legal function for Advanced Bionics globally. As part of the Sonova Legal Team, this role serves as the chief legal advisor and strategic partner to the AB President and Executive Senior Leadership Team and is a key member of the AB Leadership Team.
The role is responsible for leading all legal, compliance, ethics, governance and risk management activities globally in partnership with regional counsel. The VP, Global Legal Affairs CI provides proactive counsel on product development, regulatory matters, commercial operations, employment law, litigation, quality and compliance issues, and complex business transactions in a highly regulated Class III medical device environment.
We are looking for a pragmatic business leader who balances risk management with business objectives, demonstrates sound judgment in ambiguous situations, and champions ethical, compliant and innovative growth. This leader will also serve as a responsible AI advocate, enabling the safe and effective adoption of artificial intelligence across the organization.
Key Responsibilities
Strategic Legal Leadership
- Act as a trusted advisor to the AB President and Leadership Team.
- Provide practical, business-oriented legal guidance in support of corporate strategy, innovation, commercialization and global growth.
- Anticipate legal, regulatory and reputational risks and develop proactive mitigation strategies.
- Support mergers, acquisitions, partnerships, licensing agreements and other strategic transactions.
- Maintain an open line of communication with the Group General Counsel, ensuring timely escalation and reporting of material legal, compliance, litigation and risk matters.
Legal Function Leadership & Operations
- Develop, implement and manage the global legal strategy and operating model in alignment with business objectives and corporate priorities.
- Structure, lead and continuously develop the in-house legal function, fostering a high-performance culture and increasing levels of responsibility, contribution, engagement and professional growth across the team.
- Manage and oversee the Legal department budget, ensuring efficient allocation of resources aligned with strategic priorities and business needs.
- Establish and maintain productive relationships with external counsel and advisors globally, ensuring high-quality and cost-effective legal support.
- Drive continuous improvement, modernization and operational excellence within the Legal function, leveraging technology and data-driven decision-making.
Medical Device Regulatory & Product Counseling
- Advise on FDA, international regulatory and healthcare compliance matters affecting Class III medical devices.
- Partner with Regulatory Affairs, Clinical, Quality, R&D and Operations teams on product development, labeling, clinical studies, post-market surveillance and product lifecycle management.
- Provide legal oversight and guidance related to FDA inspections, warning letters, consent decrees, regulatory inquiries and enforcement actions.
- Counsel leadership on product safety, product performance, risk management and patient safety matters.
- Monitor changes in applicable laws and regulations and advise business leaders on emerging requirements, industry benchmarks and best practices.
Product Issues, Recalls & Field Actions
- Lead legal strategy related to product quality issues, recalls, corrections, removals, field safety notices and product holds.
- Advise executive leadership during significant product-related incidents and crisis-response situations.
- Coordinate with Regulatory, Quality, Clinical and Communications teams to ensure compliant and effective resolution of product concerns.
- Manage liability exposure arising from product performance or patient safety issues.
Litigation & Dispute Resolution
- Oversee all litigation, arbitration, government investigations and dispute resolution matters.
- Develop litigation strategies and manage internal resources and outside counsel effectively.
- Lead responses to product liability, commercial, employment, intellectual property, shareholder and regulatory disputes.
- Drive cost-effective resolution while protecting business interests and reputation.
Compliance, Ethics & Corporate Integrity
- Partner with the Vice President Compliance to lead and continuously strengthen AB's global compliance and ethics program.
- Ensure compliance with applicable healthcare laws and regulations, including FDA requirements, the Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, HIPAA and privacy regulations, the Foreign Corrupt Practices Act (FCPA), and Corporate Integrity Agreement obligations, if applicable.
- Foster a strong culture of integrity, accountability and ethical decision-making.
- Provide compliance reporting and updates to executive leadership and the Board.
Employment & Labor Law
- Advise HR and business leaders on complex employment matters, with significant expertise in California employment law.
- Provide guidance on wage and hour compliance, leaves of absence and accommodation, employee relations, workplace investigations, performance management and terminations, executive employment agreements, non-compete, confidentiality and restrictive covenant matters, and workforce restructuring.
- Partner with HR to manage employment-related litigation and risk.
AI Governance & Digital Innovation
- Champion the responsible adoption of artificial intelligence and emerging technologies throughout the organization.
- Establish and maintain governance frameworks for AI usage, data privacy, intellectual property protection, cybersecurity and regulatory compliance.
- Partner with business and technology leaders to leverage AI as a competitive advantage while ensuring ethical and compliant deployment.
- Promote AI literacy and digital fluency across leadership teams.
Corporate Governance & Board Support
- Lead and coordinate corporate governance initiatives and related matters across Advanced Bionics.
- Serve as Corporate Secretary for the Advanced Bionics Board of Managers and support the Board in fulfilling its governance responsibilities.
- Serve as Co-Chair of the Advanced Bionics Compliance and Risk Committees and provide regular reporting to executive leadership and the Board on legal, compliance and risk matters.
More about you:
- Juris Doctor from an accredited law school with strong academic credentials and admission, in good standing, to at least one State Bar. California Bar admission preferred.
- 20+ years of legal experience across a broad range of healthcare compliance and transactional matters, with a demonstrated understanding of the regulatory environment in MedTech/LifeSciences
- Strong background as a corporate generalist within the healthcare, medical device or life sciences industry, with experience across commercial transactions, regulatory matters, healthcare compliance, employment law, litigation and corporate governance.
- Considerable in-house legal experience in roles of increasing scope and responsibility.
- Experience leading people and serving as a strategic contributing member of a senior leadership team.
- Strong negotiation skills.
- Working knowledge of the healthcare landscape, including healthcare fraud and abuse laws, the Stark Law and Anti-Kickback Statute.
- Experience with medical and commercial insurance reimbursement matters.
- Ability to work independently, operate effectively under pressure and consistently meet timelines.
- Strategic mindset combined with a willingness to roll up one's sleeves and engage directly in complex matters.
- Strategic thinker with strong business acumen.
- Exceptional judgment and ability to navigate ambiguity.
- Courageous and influential leader with strong executive presence.
- Collaborative, pragmatic and solutions-oriented.
- High integrity and unwavering commitment to ethics and compliance.
- Strong people leadership and talent development capabilities.
- Growth mindset with enthusiasm for AI, digital transformation and continuous improvement.
Compensation:
- Base salary range: USD 263,000 – 335,000. This role is also bonus eligible.
- Hybrid role - based in Valencia, California.