Overview
An established global leader in medical devices focused on the vision industry is seeking an experienced Corporate Counsel – Compliance & Regulatory to join their legal team. This role involves leading compliance and regulatory initiatives related to healthcare regulations, data privacy laws, and corporate compliance standards. The organization develops technology used by eye care professionals to test, diagnose, and treat eye conditions, including corrective lenses and eyeglasses.
Responsibilities
- Advise on compliance and regulatory matters, including healthcare laws and industry standards.
- Serve as a subject matter expert on:
- Anti-Kickback Statute and Sunshine Act compliance.
- HIPAA and data privacy regulations.
- FDA regulatory requirements for medical devices.
- Develop, implement, and monitor compliance programs and policies.
- Act as Compliance Officer and HIPAA Officer for designated business units.
- Provide legal guidance on marketing, sales, and distribution practices to ensure compliance.
- Draft, review, and negotiate contracts with compliance considerations.
- Support development and management of franchise business models, including compliance with corporate practice of medicine/optometry laws; assist in maintaining compliance records; coordinate with outside counsel; monitor changes in franchise and state optometry laws.
- Support other legal matters including commercial contracts, vendor agreements, and general corporate issues.
- Conduct internal audits and risk assessments; manage investigations and remediation plans.
- Support employment law matters including employee relations, policies, and compliance.
- Lead or support compliance training initiatives, including developing materials and delivering training.
- Assist with global compliance initiatives and coordinate with international legal teams.
- Collaborate with cross-functional teams such as Legal, Regulatory Affairs, Privacy, HR, and Operations.
- Stay current on evolving healthcare regulations and industry best practices.
- Manage relationships with external counsel and regulatory agencies as needed.
Requirements
- Juris Doctor (JD) degree from a top-tier law school; active license to practice law in the U.S.
- 5–10 years of legal experience with a strong focus on healthcare compliance and regulatory matters.
- Prior experience at a law firm or in-house legal department focused on medical devices.
- Proven expertise in:
- Anti-Kickback Statute, Sunshine Act, and related state laws.
- Healthcare fraud and abuse laws and regulatory enforcement.
- HIPAA and data privacy laws.
- FDA regulations for medical devices.
- Experience serving as a Compliance Officer and HIPAA Officer preferred.
- Strong understanding of risk management and compliance frameworks.
- Experience advising on employment and franchising law matters preferred.
- Excellent communication, analytical, and problem-solving skills.
- Ability to work independently in a remote environment and manage multiple priorities.
- High degree of integrity and ability to handle sensitive or confidential information.
- Experience operating in a matrixed global organization preferred.
Preferred Qualifications
- Familiarity with compliance standards and multi-jurisdictional regulations.
- Experience managing Sunshine Act and Transparency reporting systems in a medical device setting.
- Experience in the medical device or healthcare industry.
- Knowledge of data security and cybersecurity compliance.
- Experience with employment law matters and/or franchise law.
- Experience supporting or conducting internal investigations.
- Experience drafting SOPs, policies, and compliance governance documentation.
- Working knowledge of GDPR or international privacy obligations.
Compensation & Benefits
- Annual salary range: $144,100 - $180,100.
- Eligibility for a performance bonus.
- Comprehensive benefits including medical, vision, dental insurance.
- 401(k) matching.
- Employee assistance programs.
- Paid vacation and sick leave.
Compensation may vary based on job location, role scope, qualifications, education, experience, and specialization.
Location
This is a remote position with the ability to work independently.