Regulatory Affairs Manager

Cerapedics, Inc. • Broomfield, CO

14d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience in drug/device combination product regulatory affairs preferred.
• Experience with global regulatory affairs preferred.

Responsibilities

• 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.

Benefits

• Medical, vision, and dental insurance, group life insurance, 401k matching, short- & long-term disability, potential target bonus, paid time off, 11 paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree