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.