Global Head of Product, Regulatory and Compliance Legal

About us

Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide.

Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, Colorado. OVERVIEW Healing lives through bone repair – this mission is what inspires us every day.

If that is inspiring to you as well, consider joining us as a Global Head of Product, Regulatory and Compliance Legal.

In this role, you will contribute to our mission through providing legal, healthcare regulatory and compliance guidance across the Company’s product lifecycle, ensuring 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, and leading internal training and programs to foster an ethical culture.

As a Global Head of Product, Regulatory, and Compliance Legal working on the Legal team, you will be empowered through meaningful work and career development to provide legal advice related to the development and distribution of FDA regulated medical devices in the US and applicable international markets.

A typical day will include- review of 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; and, 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.

POSITION OBJECTIVES: Brand/Product Initiatives, Marketing and Market Access Materials – 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

Health Care Professional Interactions – 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 Regulatory, Medical Education, Medical Affairs and Medical Strategy – Serve as lead legal counsel on regulatory and compliance matters for medical devices Global Healthcare Compliance — 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

). Training—Create and provide training on a wide range of issues related to labeling and promotional content, reimbursement, compliance, healthcare regulatory issues, etc. ATS provider: Paylocity. Salary: USD.