Job Description
Job Description
Description :
Celularity Inc. (Nasdaq : CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta.
The Manager / Senior Manager of Regulatory Affairs will manage regulatory activities for Celularity’s portfolio of medical devices, working closely with Product Development, Quality Control, Quality Assurance, and other teams to ensure the timely approval of new products and ongoing compliance with state and federal regulations. This role will support the regulatory strategy, contribute to regulatory submissions, and serve as a key point of contact for regulatory agencies on medical device issues.
Requirements :
Regulatory Strategy & Support :
- Support the development and execution of regulatory strategies for new product approvals, post-market surveillance, and lifecycle management of medical devices.
- Assist in the development of risk mitigation strategies and regulatory plans.
- Collaborate with cross-functional teams to ensure regulatory objectives align with broader business goals.
- Track changes in regulations, standards, and guidance that impact the company’s products and support ensuring compliance with new requirements.
Regulatory Submissions & Compliance :
Prepare, review, and submit regulatory filings such as 510(k), PMA, safety reporting, and other relevant submissions.Support the timely and accurate submission of regulatory documentation, including risk assessments, labeling, clinical trial data, and technical files.Keep up-to-date with regulatory standards and industry trends to align regulatory strategies with evolving requirements.Ensure product labeling and marketing materials are compliant with regulatory standards.Cross-Functional Collaboration :
Act as a regulatory liaison to internal teams, including Product Development, Quality Assurance, Manufacturing, and Marketing.Provide regulatory support throughout the product development lifecycle, from design and testing through to commercialization.Assist cross-functional teams in ensuring regulatory compliance during clinical trials, including proper data collection and reporting.Regulatory Agency Interaction :
Support interactions with regulatory agencies, preparing for and managing meetings with FDA, notified bodies, and other authorities.Respond to regulatory inquiries and deficiency letters, providing clarifications and additional documentation as necessary.Skills / Knowledge Required / Desired :
Bachelor’s degree in a scientific discipline; advanced degree (Master’s, PhD) or regulatory certifications (e.g., RAC) preferred.Minimum of 4 years of experience in Regulatory Affairs (6 years for Senior Manager) within the medical device industry, with at least 2 years of experience in a supervisory or management capacity (3 years for Senior Manager).Proven experience with regulatory submissions and approvals, including 510(k), PMA, and other registrations.Strong understanding of regulatory requirements, including FDA and ISO standards.Experience collaborating with cross-functional teams in a fast-paced, dynamic environment.Excellent written and verbal communication skills, with the ability to interact effectively with both regulatory agencies and internal teams.Strong analytical skills with the ability to interpret complex regulatory requirements and provide clear guidance.Ability to manage and prioritize multiple regulatory projects simultaneously.Detail-oriented, with a focus on both regulatory compliance and aligning strategies with business objectives.Working Conditions :
The incumbent will be working in an office environmentThis job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees / contractors holding this position will be required to perform any other job-related duties as requested by management.Must be authorized to work directly for Celularity in the U.S.No agency submittals accepted through this website.Celularity is an Equal Opportunity Employer
