Director of Tissue Product Development - Regulatory Affairs

Company: RegenTx
Location: San Antonio
Posted on: November 6, 2024

Job Description:

The Director of Tissue Product Development is responsible for leading all tissue 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.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.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• 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 the Product Development team.
• 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.
• Travel domestically and internationally up to 15% to attend offsite meetings, conferences, and support business initiatives.
• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
• Work overtime during weekdays and on the weekend as needed to support business/operational needs.
• Perform other related duties as assigned.Skills
  • 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 attention to detail and organizational skills.
  • Ability to work independently and in a team environment.
  • Excellent attention to detail and organization.
  • Excellent written and verbal communication skills.
  • Highest level of ethics and integrity.
  • Ability to lead and motivate the right behaviors.
  • Ability to multi-task and work in a fast-paced environment.
  • Strong technical writing skills.
  • Proficiency in Microsoft Office.Qualifications/Requirements
    • Bachelor's degree/Master's degree in in biomedical engineering, tissue engineering, mechanical engineering from an accredited college or university required.
    • 8-10+ years of experience in of product development or related field required.
    • 5+ years of leadership experience preferred.
    • Clearance of favorable background investigation required.
    • Experience with 21 CFR 1271 required.
    • 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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