Demo

Director of Product Development

Talently
San Antonio, TX Full Time
POSTED ON 3/31/2025
AVAILABLE BEFORE 4/30/2025

Location : San Antonio, TX - Relocation Packages Offered

About the Company / Opportunity :

We are a leading medical organization looking for a Director of Tissue Product Development to drive innovation in tissue-based product initiatives. This role offers an opportunity to shape product strategies, lead cutting-edge research, and ensure compliance with industry regulations, all within a collaborative environment. Your work will directly support tissue donations and significantly impact patient outcomes.

Responsibilities :

  • Develop and implement product strategies.
  • Ensure regulatory and quality compliance.
  • Establish engineering and project management processes.
  • Collaborate on regulatory strategy.
  • Conduct market analysis to discover new product opportunities and emerging trends.
  • Work closely with marketing and sales teams to develop and execute successful product launch plans.
  • Oversee project timelines, budgets, deliverables, and team accountability.
  • Stay current with FDA 21 CFR 1271 / 820, AATB, ISO standards, cGMP / CGTP, and internal policies to ensure regulatory adherence.
  • Conduct FMEAs, lead design reviews, and assess product development risks to ensure project success.
  • Manage verification and validation activities.
  • Author, review, and approve documentation related to product development.
  • Plan and oversee the execution of case studies or clinical trials to support new product development.
  • Create and implement training plans for team members on regulatory standards, design controls, and validation processes.
  • Conduct performance reviews.
  • Supervise direct reports.
  • Travel 5% to 15%.

Must-Have Skills :

  • Experience in the Medical Sector.
  • Expertise in product and project management.
  • Strong training, leadership, and management skills.
  • In-depth understanding of Regulatory Requirements.
  • Familiarity with ISO, ASTM, and AAMI guidelines and standards.
  • Extensive experience with verification and validation.
  • Proficiency in technical documentation and writing.
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