Global Head of Product, Regulatory and Compliance Legal

About Us

Cerapedics is a global, commercial-stage orthopedics company 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 its 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.

About the Role

Healing lives through bone repair – this mission inspires us every day. In this role, you will contribute to our mission by 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 to manage risk and embed compliance from design to launch. You will lead internal training and programs to foster an ethical culture.

As the Global Head of Product, Regulatory, and Compliance Legal on the Legal team, you will provide legal advice related to the development and distribution of FDA-regulated medical devices in the U.S. and applicable international markets. A typical day includes reviewing promotional content for sales and marketing, counseling on healthcare compliance issues, and supporting the general legal needs of the company with an emphasis on advising regulatory, medical strategy, medical education, and reimbursement teams.

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 teams 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, ensuring compliance with government and industry regulations (e.g., legal/ethics requirements for medical device manufacturers, anti-kickback law, anti-trust issues, anti-bribery).
• Create and provide training on labeling, promotional content, reimbursement, compliance, and healthcare regulatory issues.

Requirements

• 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.
• Legal counsel and medical device or prescription drug experience, including experience with the regulatory approval process and counseling active clinical/medical affairs organizations.
• Prior experience as a legal reviewer on a U.S. 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 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.

Work Conditions / Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.

• Regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
• Experience periods of prolonged sitting and occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
• Operate office equipment such as telephones, computers, fax machines, copiers, and grasp objects utilizing manual dexterity, including hand/finger coordination.

Travel Requirements

Details regarding travel requirements were not specified in the posting.

Benefits

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

Pay

Base Salary: $281,000.00 - $344,000.00 annually

Target Annual Bonus: Up to 25%