Global Head of Product, Regulatory and Compliance Legal

Cerapedics, Inc.•Westminster, CO

2h•$281,000 - $344,000

About The Position

Cerapedics is seeking a Global Head of Product, Regulatory and Compliance Legal to contribute to their mission of healing lives through bone repair. This role involves providing legal, healthcare regulatory, and compliance guidance across the company’s product lifecycle, ensuring adherence to applicable laws. The position requires partnering with various business teams to manage risk and embed compliance from design to launch, as well as leading internal training and programs to foster an ethical culture. The Global Head of Product, Regulatory, and Compliance Legal will provide legal advice related to the development and distribution of FDA-regulated medical devices in the US and international markets. Responsibilities include reviewing promotional content, counseling on healthcare compliance issues, and supporting the general legal needs of the company, with a focus on advising 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.
J.D. from an accredited law school; admission in good standing to at least one U.S. jurisdiction.
Minimum 15 years of relevant legal experience, including significant in-house or law firm counseling for medical devices (Class II/III).
Deep knowledge of FDA medical device promotional regulations and guidance.
Demonstrated leadership of healthcare compliance programs and HCP engagements.

Responsibilities

Serve as lead legal counsel for global brand initiatives, product labeling, marketing materials and market access materials to ensure compliance with legal and regulatory requirements.
Collaborate with business leaders and the Commercial, Medical Education, Medical Strategy and Medical Affairs team members to create solutions for developing compliant relationships with healthcare professionals and government officials.
Serve as lead legal counsel on regulatory and compliance matters for medical devices.
Serve as lead legal counsel to the Compliance function and, together with the Chief Compliance Officer, oversee the Compliance function to further develop and implement all elements of an effective global compliance program and ensure compliance with government and industry initiatives and regulations (legal/ethics requirements for medical device manufacturers, anti-kickback law, anti-trust issues, anti-bribery, etc.).
Create and provide training on a wide range of issues related to labeling and promotional content, reimbursement, compliance, healthcare regulatory issues, etc.