Director of Research & Development - Research & Product Development
San Antonio, TX, United States
The Director of Research & Product Development will be responsible for leading all new product development (NPD) initiatives for RegenTX Labs. This role will be responsible for planning and driving product strategy, overseeing design and implementation of NPD, and ensure compliance with FDA regulations, AATB standards, and other applicable regulations.
Duties & Responsibilities:
Develop and execute comprehensive strategies for research and new product development in alignment with the business objectives, including the product pipeline.
Ensure compliance with quality, regulatory, and safety standards, including FDA regulations and AATB standards.
Establish and maintain engineering and project management procedures, including design control processes.
Collaborate closely with the regulatory affairs team to develop regulatory strategies for NPD, including TRG letters, Requests for Designation (RFD), pre-RFD, premarket approvals, 510k, etc.
Conduct market research to identify new product opportunities and market trends.
Collaborate with marketing and sales teams on go-to-market strategies for new products.
Lead and develop project management activities, project schedules, budgets, and deliverables.
Establish communication channels between project teams and multi-department stakeholders to ensure alignment and efficiencies.
Oversee the Research & Product Development project timelines, understand critical paths, dependencies, and enforce accountability.
Support planning and execution of new company initiatives, such as equipment onboarding, and product support.
Define product goals to guide the design process, and refine design concepts based on market feedback.
Participate in risk management activities, including FMEAs, and oversee design reviews to assess project progress and product design.
Oversee planning and execution of verification and validation activities, ensuring compliance with industry standards and regulations.
Track and establish product financial metrics, including Gross Margin and COGS, and determine production forecasts post-launch.
Support the operations team to meet forecasted quantities and improve manufacturing efficiency.
Author, review, and approve documents related to research and product development, including procedures, protocols, marketing materials, and technical reports.
Support and oversee execution of validation, verification, and qualification protocols to ensure regulatory compliance.
Work closely with QA, RA, and other departments to develop quality supplier agreements, labeling, product claims, regulatory strategies, and sales & marketing materials.
Support the investigation of product quality events and implementation of corrective and preventive actions (CAPA).
Support the planning and execution of case studies or clinical studies for new products.
Develop training plans for direct reports on regulatory requirements, design controls, and validations.
Ensure effective management of laboratory facilities.
Establish and maintain working relationships with vendors and consultants.
Oversee the patenting of new technologies and processes, fostering a positive and productive work environment across both Research and Product Development teams.
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as
appropriate), and industry standards
Conduct performance reviews, monitor annual goals, and establish performance improvement plans as needed.
Recruit, interview, and select personnel for hire.
Attend/participate in offsite business meetings/conferences.
Perform other related duties as assigned.
Travel domestically and internationally up to 10% to attend offsite meetings, conferences, and support business initiatives.
Skills & Abilities:
Extensive knowledge of applicable government regulations.
Extensive knowledge of ISO, ASTM, and AAMI guidance and standards.
Extensive knowledge of verification and validation practices.
Ability to inform and educate department heads on applicable regulations and policies that require compliance.
Excellent written and verbal communications skills
Strong leadership skills.
Excellent attention to detail and organizational skills.
Education & Experience:
Bachelor\'s degree or master’s degree in biomedical engineering, tissue engineering, mechanical engineering or related field required.
8-10+ years of product development experienced required.
5+ years of leadership experience preferred.
Experience with 21 CFR 820.30 Design Controls required.
Proficiency in project management required.
Experience with allografts and/or medical devices required.
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