Program Manager, Regulatory Affairs

Role Summary

Program Manager, Regulatory Affairs responsible for regulatory affairs requirements for medical devices and biologics, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Develop regulatory strategies and submissions for new and modified products to the FDA and international regulatory bodies, and provide regulatory support for changes to US marketed products.

Responsibilities

• Working closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation.
• Providing input on and review of protocols and reports including process validation, equipment qualification, and shelf-life studies.
• Ensuring regulatory compliance with QSR and cGMP requirements and stay apprised of ICH, FDA and EU requirements.
• Evaluating changes to determine the filing requirements and impact on AATB certifications, state licenses, and FDA registrations.
• Review of labeling changes, and advertising and promotional material.
• Review of complaints for medical device reporting (MDR) requirements.

Qualifications

• Required: A minimum of 5 years of relevant experience in the biotech industry; a minimum of 3 years of experience in developing regulatory strategies, planning and preparing regulatory submissions.
• Preferred: Experience with regulatory product lifecycle management.
• Required: Regulatory experience with development of Medical Device and Biologic products, including PMA, BLA and/or 510(k).
• Required: Good working knowledge of relevant regulations and industry standards. Strong organizational, interpersonal and written/verbal communication skills.
• Required: Experience with technical aspects of product development and manufacturing.

Skills

• Working knowledge of FDA and International Biologics/Drug/Device regulations is preferred.
• Prior experience with medical devices development and registrations is a plus.
• Ability to prioritize and multi-task projects independently is preferred.

Education

• Required: BS degree in science, technology, engineering, or mathematics.
• Preferred: Degree in science, technology, engineering, or mathematics.