Regulatory Affairs Manager

Description

Cerapedics is a global, commercial‑stage ortho‑biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world‑wide. Cerapedics’ product, i‑FACTOR, is FDA PMA approved for cervical use in the United States.

Cerapedics’ next‑generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.

Cerapedics is a global, commercial‑stage ortho‑biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world‑wide. Cerapedics’ product, i‑FACTOR, is FDA PMA approved for cervical use in the United States.

Cerapedics’ next‑generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.

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 Regulatory Affairs Manager.

In this role, you will contribute to our mission through assisting with managing and executing the activities of Regulatory Affairs. As a Regulatory Affairs Manager working on the Regulatory Affairs team, you will be empowered through meaningful work and career development to coordinate closely with cross‑functional partners and others on the development, submission, and prosecution of Regulatory filings.

• Develop, author, assemble, publish and submit IDE Annual Reports, Post‑Approval Study Annual Reports, and PMA Annual Reports, ensuring timely submission in accordance with FDA Approvals.
• Work collaboratively with subject matter experts and business partners to identify and gather data required for submission, including data from clinical, non‑clinical, and manufacturing.
• Monitor regulatory changes and assess their impact on organizational processes and products.
• Review and approve technical documentation (e.g. protocols, reports, procedures) to ensure alignment with the PMAs. Evaluate changes for incorporation into an Annual Report or other post‑market submission.
• Maintain FDA device listing and site registration.
• Collaborate with stakeholders such as R&D, Engineering, Quality, Clinical and Operations teams to ensure regulatory alignment.

• Good planning and prioritization skills.
• Strong interpersonal and team skills.
• Strong decision‑making skills.
• Good writing skills.
• Good computer and word processing skills.
• Adaptable to various job duties as necessary.

• Minimum of a technical college degree in scientific discipline, in combination with applicable training.
• Minimum of 4 years of experience in US Class III medical device regulatory affairs.
• Experience in drug/device combination product regulatory affairs preferred.
• Experience with global regulatory affairs preferred.

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…