Director of Compliance

Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.

Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.

Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.

Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.

Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.

What you will be doing:

• Ensure Insightec maintains an effective compliance program to comply with laws and policies applicable to its business around the world as a global medical device company.
• Advise and assist the legal team, senior management and the Board of Directors in fulfilling their responsibilities to ensure compliance.
• Chair and run management compliance committee charged with overseeing the company’s Healthcare Professional (HCP) engagements, sponsorships, donations, grants and fellowships.

Manage the company’s HCP and third party seller compliance program, including:

• A vetting process for HCP consultants and third party seller selection;
• Review process HCP engagements and events to ensure alignment with applicable laws and codes, such as industry codes of ethics (AdvaMed Code, MedTech Europe, APACMed); and
• Inter-departmental collaboration on systems for tracking, auditing and reporting HCP spend and interactions, including aggregate spend and transparency reporting.
• Manage the company’s Enterprise Risk Management program to identify and monitor significant risks associated with its business and appropriate mitigation actions.

Specific additional compliance responsibilities include the following:

• Maintain an effective compliance program in accordance with recommended best practices, including guidance from governmental authorities (e.g., US DoJ, HHS-OIG; UK SFO) and from applicable industry codes (e.g., AdvaMed, MedTech Europe, APACMed).
• Update and maintain the company’s Compliance Action Plan and Monitoring and Auditing Plan and drive tasks to completion in a timely fashion.
• Ensure the company’s Code of Conduct and other policies are adequate and current and understood through periodic training, both in person and using information technology.
• Manage ethics hotline reports and address compliance concerns, as applicable.
• Manage compliance investigations, corrective actions, record keeping, and disciplinary actions, as needed.
• Prepare reports and provide quarterly updates to the company’s ethics & compliance committees at senior executive and Board level.
• Update and maintain data and security policies including HIPAA, GDPR, CCPA and others, as industry rules evolve.
• Serve as Company’s Data Protection Officer for purposes of GDPR
• Ensure compliance with company policies and applicable regulations for distributors, sales agents and other third-party sellers, including due diligence, contracting, training and monitoring.
• Support ownership of compliance imperatives by business leaders through needs assessments, committee meetings and other operating mechanisms.
• Update and maintain internal Compliance Corner website as a resource for all policies, procedures, and training materials.
• Provide training and practical guidance to sales, marketing, medical affairs and R&D teams on compliant HCP engagement standards.
• Serve as compliance helpdesk for all policy-related questions or general guidance.

Qualifications:

• Excellent academic credentials.
• 5+ years of relevant work experience, preferably in the medical device or life sciences industry and experience with a global organization.
• Strong analytical thinking, high integrity, result-oriented, self-starter, with hands-on approach.
• Ability to work with dynamic multinational and interdisciplinary teams.
• Strong written and verbal communication and presentation skills