Director, Regulatory Affairs

Description:

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 Companys 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 for medical device manufacturers, anti-kickback law, anti-trust issues, anti-bribery, etc.).
• TrainingCreate and provide training on a wide range of issues related to labeling and promotional content, reimbursement, compliance, healthcare regulatory issues, etc.

POSITION 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.

EDUCATION AND PREFERRED TRAINING 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

WORK CONDITION/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.

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

TRAVEL REQUIREMENTS:

BENEFITS/COMPENSATION (including, but not limited to):

• Medical and dental insurance, group life insurance , 401k matching, long term disability, potential target bonus, paid time off.

SALARY RANGE: $281,000.00 - $344,000.00

Base Salary: Annually

Target Annual Bonus: Up to 25%

Position will be posted through July 26th, 2026

EEO STATEMENT:

Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Compensation details: 281000-344000 Yearly Salary

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