Global Head of Product, Regulatory and Compliance Legal

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🔥 0 minutes ago

⛰️ Colorado – Remote

⛰️ Colorado – Remote

💵 $281k - $344k / year

⏰ Full Time

🔴 Lead

⚖️ Legal Counsel / General Counsel

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Globaltech Medical Devices

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Globaltech Medical Devices es una empresa líder en innovación médica, dedicada a impulsar avances en cirugía de alta especialidad. A través de tecnología de punta y una sólida colaboración con expertos médicos, ofrecen soluciones que transforman el cuidado de la salud y mejoran la calidad de vida de las personas. Su enfoque está en dispositivos médicos de neurocirugía y ortopedia.

📋 Description

• Contribute to the mission through providing legal, healthcare regulatory and compliance guidance across the Company’s product lifecycle • Ensure adherence to applicable laws while partnering with marketing, sales, medical strategy, medical education, reimbursement, regulatory, clinical publications and other business teams as requested to manage risk and embed compliance from design to launch • Lead internal training and programs to foster an ethical culture • Review a high volume of promotional content for sales and marketing and other content for healthcare professionals, patients, and managed care organizations as well as training and similar materials • Routine counseling on healthcare compliance issues including close interaction with the General Counsel and senior management team • In conjunction with the Deputy General Counsel, providing support for the general legal needs of the company, with an emphasis on advising the regulatory, medical strategy, medical education, and reimbursement teams.

🎯 Requirements

• Legal counsel and medical device or prescription drug experience including experience with regulatory approval process, counseling active clinical/medical affairs organizations • Prior experience as a legal reviewer on a US promotional review committee • Experience working with and advising Medical Education and Medical Affairs • Strong understanding of healthcare laws and the healthcare compliance and enforcement environment • Ability to actively work to identify, analyze and mitigate potential risks to the organization • Prior experience supporting a product launch highly preferred • Excellent judgment, business acumen, and communication skills; proven ability to influence cross-functional leaders and make clear, timely decisions.

🏖️ Benefits

• Medical and dental insurance • Group life insurance • 401k matching • Long term disability • Potential target bonus • Paid time off