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.