Program Manager, Regulatory Affairs

About This Role

This role involves primarily handling regulatory affairs requirements for medical devices and biologic products. You will develop regulatory strategies and submissions for new and modified products to the FDA and International regulatory bodies, also providing regulatory support and guidance for product changes to US marketed products.

Responsibilities

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

Requirements

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

Qualifications

• BS degree in science, technology, engineering, or mathematics preferred
• Minimum of 5 years of relevant experience in the biotech industry required; a minimum of 3 years of experience in developing regulatory strategies, planning and preparing regulatory submissions required.

Nice to Have

• Experience with regulatory product lifecycle management
• Working knowledge of FDA and International Biologics/Drug/Device regulations
• Prior experience with medical devices development and registrations
• Ability to prioritize and multi-task projects independently

Benefits