Director of Compliance

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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INSIGHTEC

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Ensure Insightec maintains an effective global compliance program for 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 HCP engagements, sponsorships, donations, grants, and fellowships • Manage HCP consultant vetting and third-party seller selection processes • Review HCP engagements and events for compliance with applicable laws and industry codes • Collaborate across departments on systems for tracking, auditing, and reporting HCP spend and interactions • Manage the Enterprise Risk Management program and mitigation actions • Maintain the compliance program, Compliance Action Plan, and Monitoring and Auditing Plan • Maintain the Code of Conduct and policies and deliver periodic training • Manage ethics hotline reports, 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 • Maintain data and security policies, including HIPAA, GDPR, and CCPA • Serve as the Company’s Data Protection Officer for GDPR • Ensure compliance for distributors, sales agents, and third-party sellers through due diligence, contracting, training, and monitoring • Support compliance ownership by business leaders through needs assessments and committee meetings • Maintain the internal Compliance Corner website • Provide training and practical guidance to sales, marketing, medical affairs, and R&D teams • Serve as compliance helpdesk for policy-related questions and general guidance

🎯 Requirements

• 5+ years of relevant work experience • Preferably experience in the medical device or life sciences industry • Experience with a global organization preferred • Excellent academic credentials • Strong analytical thinking • High integrity • Result-oriented, self-starter with a hands-on approach • Ability to work with dynamic multinational and interdisciplinary teams • Strong written and verbal communication and presentation skills • Knowledge of compliance requirements including HIPAA, GDPR, CCPA, AdvaMed Code, MedTech Europe, and APACMed • Ability to manage Healthcare Professional and third-party seller compliance programs • Ability to manage Enterprise Risk Management programs • Ability to serve as Data Protection Officer for GDPR purposes

🏖️ Benefits

• Flexible work environment • Life-work balance philosophy • Competitive perks and benefits in each region • Professional growth and internal talent development opportunities • Training and professional development opportunities • Meaningful work focused on transforming patient lives through incisionless surgery