What are the responsibilities and job description for the Director, Regulatory Affairs & Quality Assurance position at JHNA?
Overview
The mission of the Advanced Regenerative Manufacturing Institute (ARMI) is to advance the U.S. bioeconomy. ARMI is building a highly diverse, competitive, capable and innovative domestic cell, tissue and organ manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury, as well as establishing the trained and ready workforce essential for that ecosystem. ARMI's efforts are centered in Manchester, NH with national and international impact.
The Impact That You Will Make
The Director of RA/QA is critical to our success. In this role, you will lead 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 Chief Regulatory Officer.
Your Role
The mission of the Advanced Regenerative Manufacturing Institute (ARMI) is to advance the U.S. bioeconomy. ARMI is building a highly diverse, competitive, capable and innovative domestic cell, tissue and organ manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury, as well as establishing the trained and ready workforce essential for that ecosystem. ARMI's efforts are centered in Manchester, NH with national and international impact.
The Impact That You Will Make
The Director of RA/QA is critical to our success. In this role, you will lead 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 Chief Regulatory Officer.
Your Role
- Translate organizational goals into actionable initiatives for the Regulatory team
- Provide support, guidance, and mentorship to direct reports within the Regulatory team
- 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
- Review FDA submission packages; attend FDA teleconferences
- Present on current regulatory affairs at conferences and educational seminars
- 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 10 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
- Strong leadership and coaching skills
- 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
- Collaborative attitude, sense of curiosity, and eagerness to impact positive change
