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Globally recognized for exceptional product performance and versatility, Fotona develops award-winning aesthetic, medical, and dental lasers. With over 50 years of laser expertise and industry leadership, Fotona has sold over 30,000 lasers worldwide with distribution in over 60 countries. Fotona’s reputation for excellence is earned from its dedication to R&D, unparalleled quality, reliability, ease of use, and durability.

Fotona is currently seeking a  seasoned Director of Compliance to lead regulatory and corporate compliance efforts, with a strong focus on FDA readiness and enterprise-wide policy governance as we expand our US presence.

This is a high-impact leadership role responsible for shaping Fotona’s compliance infrastructure, partnering with senior stakeholders, and ensuring sustained regulatory excellence across our U.S. operations. Based in our Irving, TX office, this position plays a vital role in supporting regulatory interactions and building operational resilience in a dynamic, fast-paced environment.

Key Leadership Responsibilities:

Regulatory & FDA Compliance Strategy

+ Serve as the organizational lead for all FDA-related compliance activities and regulatory interactions.

+ Lead internal readiness for inspections and audits; manage FDA investigations and remediation efforts.

+ Drive proactive risk identification, mitigation planning, and compliance program enhancement.

+ Ensure alignment of promotional, educational, and digital content with regulatory standards, including social media audits.

+ Build and lead FDA training programs to support continuous compliance awareness and preparedness.

Enterprise Policy & Governance

+ Develop and manage corporate compliance policies in coordination with Legal and HR.

+ Provide guidance and oversight on contract governance, from template management to legal review coordination.

+ Establish and oversee the company’s ethics hotline and related investigation protocols.

+ Serve as a trusted advisor to business units on contractual and regulatory implications of business initiatives.

+ Lead implementation and optimization of a contract management system to ensure transparency and consistency.

Commercial & Marketing Compliance

+ Partner with Marketing leadership to ensure claims, advertising, and promotional materials meet FDA and FTC standards and other regulatory requirements.

+ Oversee substantiation processes and policy frameworks to mitigate reputational and legal risk.

+ Develop governance models, training programs, and SOPs to align commercial activity with evolving regulatory landscapes.

Ideal Profile:

+ 7+ years of experience in regulatory affairs, legal compliance, or risk management, ideally within the medical device, life sciences, or healthcare sector.

+ Deep expertise in FDA compliance, inspection readiness, and regulatory liaison.

+ Demonstrated success leading cross-functional compliance programs in a matrixed organization.

+ Strong business acumen and the ability to translate regulatory requirements into operational strategies.

Requirements:

+ Bachelor’s degree required; advanced degree in Law, Compliance, or related field preferred.

+ Excellent interpersonal, written, and verbal communication skills, with a collaborative and decisive leadership style.

+ Ability to work onsite in Fotona's Irving, Texas office, Monday through Friday.

+ Ability to work at a computer and sit for extended periods.

Compensation:

+ Competitive pay based on experience.

+ Excellent benefits package including Medical, Dental, Vision, and Life Insurance.

+ 401(k) with matching.

+ Opportunity to develop and grow a career within a fast-growing and industry-leading company.

*Fotona is an equal-opportunity employer.

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