What are the responsibilities and job description for the Director, Medical Device Regulatory Affairs position at Celularity?

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 Director of Regulatory Affairs will oversee and manage all regulatory activities for Celularity’s portfolio of medical devices. The individual will work closely with senior leadership, Product Development, Quality Control, Quality Assurance, and other groups to ensure the timely approval of new products and ongoing compliance with state and federal regulatory requirements. The Director will be responsible for guiding the company’s regulatory strategy, preparing regulatory submissions, and serving as the primary point of contact for regulatory agencies regarding medical device issues.

Requirements :

Regulatory Strategy & Leadership :

Develop and implement regulatory strategies for new product approvals, post-market surveillance, and lifecycle management of medical devices.
Develop and implement risk mitigation strategies and plans
Collaborate with senior leadership to align regulatory objectives with company business goals.
Monitor and assess changes in regulations, standards, and guidance that may impact the company’s products, ensuring compliance with new requirements.
Regulatory Submissions & Compliance :

Prepare, review, and submit regulatory filings such as 510(k), PMA, safety reporting, periodic reporting, and other relevant submissions.

Ensure timely and accurate submission of regulatory documentation, including risk assessments, labeling, clinical trial data, and technical files.

Maintain up-to-date knowledge of regulatory standards and industry trends, ensuring that regulatory strategies align with evolving regulatory landscapes.

Ensure product labeling and marketing materials comply with regulatory requirements.

Cross-Functional Collaboration :

Serve as the primary regulatory contact regarding medical device issues for internal teams, including Product Development, Quality Assurance, Manufacturing Operations and Marketing.

Provide regulatory guidance and support throughout the product development lifecycle, from design and testing through commercialization.

Support cross-functional teams in designing and conducting clinical trials, ensuring regulatory compliance in data collection and reporting.

Regulatory Agency Interaction :

Lead interactions with regulatory agencies, including preparing for and managing meetings with FDA, notified bodies, and other regulatory authorities.

Respond to regulatory inquiries and deficiency letters, providing clarifications and necessary documentation as required.

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 8-10 years of experience in Regulatory Affairs within the medical device industry, with at least 3 years in a leadership role.

Proven track record of successful regulatory submissions and approvals, including 510(k), PMA, and other registrations.

Strong understanding of regulatory requirements and medical device regulations (FDA, ISO, etc.).

Experience working with cross-functional teams in a fast-paced, dynamic environment.

Excellent written and verbal communication skills, with the ability to interact effectively with regulatory agencies and internal stakeholders.

Strong analytical skills, with the ability to interpret complex regulatory requirements and provide clear guidance.

Ability to prioritize and manage multiple regulatory projects simultaneously.

Detail-oriented with the ability to see the big picture and align regulatory strategies with business objectives.

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Director, Medical Device Regulatory Affairs

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