Regulatory Affairs Manager at Cerapedics, Inc.

Broomfield, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

08 May, 26

Salary

140000.0

Posted On

07 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Planning, Prioritization, Interpersonal Skills, Team Skills, Decision-Making, Writing Skills, Computer Skills, Word Processing Skills, Adaptability

Industry

Biotechnology Research

Description

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&D, Engineering, Quality, Clinical and Operations teams to ensure regulatory alignment. Requirements POSITION 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. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: 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. 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. Moderate to minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to plan. TRAVEL REQUIREMENTS: N/A BENEFITS/COMPENSATION (including, but not limited to): Medical, vision, and dental insurance, group life insurance, 401k matching, short- & long-term disability, potential target bonus, paid time off, 11 paid holidays. SALARY RANGE: $130,000 - $140,000 Base Salary: Annually Target Annual Bonus: 15% Position will be posted through: March 8, 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.

Responsibilities

The Regulatory Affairs Manager will manage and execute regulatory activities, including the development and submission of regulatory filings. This role involves collaboration with cross-functional partners to ensure compliance with FDA regulations.