What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at JHNA?
Overview
Our goal is to improve lives by restoring or replacing the function of damaged cells, tissues, and organs for patients. BioFabUSA's mission is to develop a highly diverse, competitive, capable and innovative cell, tissue, and organ ecosystem that ensures a low-cost and high-quality domestic healthcare system, and domestic leadership in the biofabrication industrial base.
The Impact That You Will Make
Senior Regulatory Affairs Consultants are critical to our success. In this role, you will contribute to a strong Regulatory team, devising robust regulatory strategies for ARMI members and internal projects, while ensuring compliance to federal regulations. Products include complex biologics, devices, and combination products, with many in the preclinical and clinical spaces. This position reports to the Director of RA/QA.
Your Role
Our goal is to improve lives by restoring or replacing the function of damaged cells, tissues, and organs for patients. BioFabUSA's mission is to develop a highly diverse, competitive, capable and innovative cell, tissue, and organ ecosystem that ensures a low-cost and high-quality domestic healthcare system, and domestic leadership in the biofabrication industrial base.
The Impact That You Will Make
Senior Regulatory Affairs Consultants are critical to our success. In this role, you will contribute to a strong Regulatory team, devising robust regulatory strategies for ARMI members and internal projects, while ensuring compliance to federal regulations. Products include complex biologics, devices, and combination products, with many in the preclinical and clinical spaces. This position reports to the Director of RA/QA.
Your Role
- Attend meetings and teleconferences with clients seeking strategic regulatory guidance
- Provide expertise related to regulatory strategy, preclinical and clinical study design, CMC, and other topics
- Draft and review FDA meeting request packages; attend FDA teleconferences
- Contribute to the planning, development, organization, writing, and editing of regulatory applications for BioFabConsulting members/clients
- Provide guidance and mentorship to more junior regulatory staff
- Create original regulatory education materials, such as workshop content and web pages
- Provide input and assistance on ARMI | BioFabUSA projects in the technical, education and workforce development, and membership areas on an as-needed basis
- Continually bolster personal knowledge by studying trends and developments in regulatory affairs, participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations
- Attend events, workshops, and meetings organized by ARMI | BioFabUSA or by ARMI members
- B.S. or B.A. degree required; degree in life sciences or engineering is preferred
- Minimum of 8 years of direct work experience in human medical product regulatory affairs; experience with biologics preferred
- Thorough knowledge of U.S. FDA medical product regulations, current industry practices, and experience with interpretation and application of said regulations and practices
- Ability to influence colleagues, clients, and Institute members at all levels in the organization
- Exceptional written and verbal communication skills
- Proficient with Microsoft software products
- Ability to multi-task, meet deadlines, and set priorities
- Ability to work independently and thrive in a fast-paced, rapidly changing environment
- Collaborative attitude, sense of curiosity, and eagerness to impact positive change
