
201 - 500 employees
🏭 Manufacturing
🏥 Healthcare
💊 Pharmaceuticals
💰 $100M Debt Financing on 2022-08
Manufacturing • Healthcare • Pharmaceuticals
INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.
🔥 1 minute ago
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201 - 500 employees
🏭 Manufacturing
🏥 Healthcare
💊 Pharmaceuticals
💰 $100M Debt Financing on 2022-08
Manufacturing • Healthcare • Pharmaceuticals
INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.
• Ensure Insightec maintains an effective global compliance program applicable to its medical device business • Advise and assist the legal team, senior management, and Board of Directors on compliance responsibilities • Chair and run the management compliance committee overseeing Healthcare Professional engagements, sponsorships, donations, grants, and fellowships • Manage HCP consultant vetting and third-party seller selection processes • Review HCP engagements and events for alignment with applicable laws and industry ethics codes • Collaborate across departments on systems for tracking, auditing, and reporting HCP spend and interactions • Manage aggregate spend and transparency reporting • Manage the Enterprise Risk Management program and mitigation actions • Maintain the Compliance Action Plan and Monitoring and Auditing Plan • Maintain the Code of Conduct and company policies and support periodic training • Manage ethics hotline reports and compliance concerns • Manage compliance investigations, corrective actions, record keeping, and disciplinary actions • Prepare reports and provide quarterly updates to senior executive and Board-level ethics and compliance committees • Update and maintain data privacy and security policies as privacy rules evolve • Serve as the Company’s Data Protection Officer for GDPR and Privacy Officer • Ensure compliance for distributors, sales agents, and third-party sellers through due diligence, contracting, training, and monitoring • Support business leaders in owning compliance imperatives through needs assessments, committee meetings, and operating mechanisms • Maintain the internal Compliance Corner website with 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 policy-related questions and general guidance
• Excellent academic credentials • 5+ years of relevant work experience • Preferably experience in the medical device or life sciences industry • Experience with a global organization preferred • Strong analytical thinking • High integrity • Result-oriented and self-starter mindset • Hands-on approach • Ability to work with dynamic multinational and interdisciplinary teams • Strong written and verbal communication skills • Strong presentation skills • Knowledge of compliance programs, applicable laws, governmental guidance, and industry codes such as AdvaMed, MedTech Europe, and APACMed • Knowledge of data privacy and security requirements including HIPAA, GDPR, and CCPA • Ability to manage HCP and third-party seller compliance programs • Ability to manage enterprise risk management programs • Ability to conduct compliance investigations, corrective actions, record keeping, and disciplinary actions • Ability to provide compliance training and practical guidance • Ability to serve as Data Protection Officer for GDPR and Privacy Officer
• Flexible work environment • Life-work balance philosophy • Competitive perks and benefits (region-specific) • Professional growth and internal talent development opportunities • Training and professional development opportunities • Meaningful work transforming patient lives through innovative incisionless surgery
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