Regulatory Affairs Manager

Cerapedics • Westminster, CO

16d • $130,000 - $140,000

About The Position

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