Regulatory Open Forum

Director, Regulatory Projects & Processes
Location: Manchester, NH
Type: Full Time
Min. Experience: Mid Level

Compensation
Contact for Details

Overview
The Advanced Regenerative Manufacturing Institute ("ARMI"), a New Hampshire membership-based, not-for-profit corporation whose mission is to seeks to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. ARMI was selected by the Department of Defense to operate the BioFabUSA program, which will be the recipient of $80 million in federal funds over the next 5-6 years.

Position Description
This position oversees the administration and flow of BIoFabConsulting projects and assists in development of regulatory processes to help support consulting projects and other regulatory programs. The position directs, manages, and tracks all consulting projects within BioFabConsulting. This position also represents ARMI | BIoFabUSA and BioFabConsulting at meetings and conferences, facilitating consulting agreements with member/clients, and promoting ARMI | BIoFabUSA and BioFabConsulting. This is a full-time (40 hours per week), salaried position.

Responsibilities

• Direct and manage consulting projects within BioFabConsulting (40% of time)
• Aid in the development of regulatory processes (20% of time)
• Aid in the preparation of regulatory documents and applications (20% of time)
• Assist in non-regulatory ARMI | BioFabUSA projects (10% of time)
• Attend ARMI | BioFabUSA-related and member-related events (8% of time)
• Attend necessary and related training (2% of time)

Travel Required
Occasional Travel – You may be expected to travel for this position

Qualifications

• B.S. or B.A. degree is required.
• A minimum of 3+ years industry experience in US regulatory affairs activities related to all phases of clinical development for regulated medical products.
• Direct experience with medical device and/or biologics development. Experience in regenerative medicine products highly desired; experience in combination products is a plus.
• Direct experience in the development and submission of applications to regulatory agencies; direct experience working with the Food and Drug Administration's (FDA) Office of Tissue and Advanced Therapies (OTAT) will be a plus.
• Strong knowledge of regulations, current industry practices, and strong experience with interpretation and application of said regulations and practices.
• External-facing with excellent written and verbal communication, presentation, and facilitation skills.
• Strong teamwork skills, including the ability to build effective relationships within ARMI | BioFabUSA and with external partners, at all levels, from technical staff to executives.
• Demonstrated ability to multi-task, meet deadlines, and set priorities.
• Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
• Excellent operational skills including planning, organizing, and the ability to build effective relationships.
• Ability to work independently and thrive in a fast-paced environment.

Technical Writer
Location: Manchester, NH
Type: Part Time to Full Time
Min. Experience: Mid Level

Compensation
Contact for Details

Overview
The Advanced Regenerative Manufacturing Institute ("ARMI"), a New Hampshire membership-based, not-for-profit corporation whose mission is to seeks to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. ARMI was selected by the Department of Defense to operate the BioFabUSA program, which will be the recipient of $80 million in federal funds over the next 5-6 years.

Position Description
This position serves as support to the ARMI/BioFabUSA and BioFabConsulting regulatory staff. Duties include writing and editing of regulatory submissions, and assisting the Director of Regulatory Projects and Processes in development of regulatory educational materials. This can be either a part-time (20 hours per week) or full-time (40 hours per week) position.

Responsibilities

• Write and edit regulatory submissions for BioFabConsulting (80% of time)
• Aid in the development of regulatory education materials (20% of time)

Travel Required
Ability to travel is not an expectation for this position

Qualifications

• B.S. or B.A. degree is required; degree in life sciences or engineering is preferred.
• Proven experience writing applications for submission to the US Food and Drug Administration (FDA) for regulated medical products.
• Excellent written and verbal communication skills.
• Direct experience writing Investigational New Drug (IND), Biologics License Application (BLA), and 510(k) Premarket Notification applications is desired; direct experience writing INDs and BLAs for submission to the FDA's Office of Tissue and Advanced Therapies (OTAT) will be a plus.
• Proficiency in MS Office.
• Strong teamwork skills, including the ability to build effective relationships within ARMI/BioFabUSA.
• Ability to multi-task, meet deadlines, and set priorities.
• Ability to work independently and thrive in a fast-paced environment.

**For more information or to apply, visit: Careers - Advanced Regenerative Manufacturing Institute

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Katrina Wells
Regulatory Intern
Manchester NH
United States
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