Director of Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that Insightec upholds an effective global compliance program for its medical device operations.

• Provide counsel and support to the legal team, senior management, and Board of Directors regarding compliance obligations.

• Lead and facilitate the management compliance committee that oversees Healthcare Professional (HCP) engagements, sponsorships, donations, grants, and fellowships.

• Oversee the vetting process for HCP consultants and selection of third-party sellers.

• Review HCP engagements and events to ensure adherence to relevant laws and industry standards.

• Collaborate with various departments to establish systems for tracking, auditing, and reporting HCP expenditures and interactions.

• Manage the Enterprise Risk Management program and associated mitigation strategies.

• Sustain the compliance program, including the Compliance Action Plan and Monitoring and Auditing Plan.

• Uphold the Code of Conduct and associated policies while delivering periodic training sessions.

• Handle ethics hotline reports, compliance investigations, corrective measures, record keeping, and disciplinary actions.

• Prepare reports and offer quarterly updates to senior executives and ethics and compliance committees at the Board level.

• Maintain data and security policies, encompassing HIPAA, GDPR, and CCPA compliance.

• Act as the Company’s Data Protection Officer for GDPR compliance.

• Ensure compliance for distributors, sales agents, and third-party sellers through due diligence, contracting, training, and monitoring efforts.

• Promote compliance ownership among business leaders through needs assessments and committee engagements.

• Manage the internal Compliance Corner website.

• Provide training and practical guidance for sales, marketing, medical affairs, and R&D teams.

• Function as a compliance helpdesk for policy inquiries and general guidance.

⛳️ Requirements

• A minimum of 5 years of relevant work experience.

• Preferred experience in the medical device or life sciences sector.

• Experience within a global organization is advantageous.

• Excellent academic qualifications.

• Strong analytical skills.

• High level of integrity.

• Results-driven self-starter with a proactive approach.

• Ability to collaborate with dynamic multinational and interdisciplinary teams.

• Exceptional written and verbal communication and presentation abilities.

• Familiarity with compliance regulations, including HIPAA, GDPR, CCPA, AdvaMed Code, MedTech Europe, and APACMed.

• Competency in managing compliance programs for Healthcare Professionals and third-party sellers.

• Capability to manage Enterprise Risk Management initiatives.

• Ability to serve as the Data Protection Officer for GDPR compliance.

🏝️ Benefits

• Flexible work environment.

• Philosophy promoting life-work balance.

• Competitive perks and benefits tailored to each region.

• Opportunities for professional growth and internal talent development.

• Access to training and professional development initiatives.

• Engaging work focused on transforming patient lives through incisionless surgery.