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.