Regulatory Affairs Manager

Cerapedics Inc

Westminster, Colorado, United States

Westminster, Colorado, United States

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About

Description: ABOUT US 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. 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 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. POSITION OBJECTIVES: 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

Westminster, Colorado, United States

Languages

English

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