Senior Technical Program Manager, Med Devices & Regulatory

BioTissue Holdings Inc; Miami (FL); On-site; USD 124,000 - 156,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Retirement Savings Plan

Paid Time Off & Holidays

Equity or Stock Programs

Job summary

BioTissue Holdings Inc. seeks a Senior Technical Program Manager for Product Development in Miami, FL.

You will lead complex cross-functional programs from concept to commercialization within medical device and combination products, guiding strategy, planning, budgeting, and risk management across the lifecycle. You will coordinate IND/BLA activities and work with Regulatory, Quality, Clinical, and Manufacturing teams to align device and biologics strategies, ensuring successful program delivery

Qualifications

• 8+ years of experience in regulated product development, technical operations, CMC, engineering, or a life sciences environment.
• 5+ years leading cross-functional product development projects or programs with plans, risks, budgets, and governance.
• Experience supporting biologics development and IND/BLA submissions preferred; medical device/combination product is advantageous.
• Knowledge of FDA regulations (e.g., 21 CFR Part 820, 211, 212) and ICH/guidances, cGMP, ISO 13485 concepts.
• Bachelor's in Engineering or related technical field required; advanced degree preferred.

Responsibilities

• Lead programs through feasibility, development, verification/validation, clinical development, regulatory submission, transfer, and launch readiness.
• Develop integrated plans, schedules, budgets, resources, and critical paths; manage dependencies.
• Translate product, regulatory, and commercial strategies into cross-functional work plans.
• Run core team meetings, assign ownership, track actions, raise risks with options.
• Coordinate external labs, CROs, CMOs, and other development partners.
• Ensure alignment with business cases, portfolio priorities, and milestones.
• Author development plans, stage-gate deliverables, and governance calendars.

Skills

Regulated product development

Stage-gate governance

Design controls

Risk management

Cross-functional leadership

Regulatory affairs coordination

Executive communication

Technical writing

Quality by design

IND/BLA submissions knowledge

Education

Bachelor's degree in Engineering or related

Tools

Project scheduling tools

Portfolio reporting tools

Document management systems

Quality systems knowledge

Job description

BioTissue Holdings Inc. seeks a Senior Technical Program Manager for Product Development in Miami, FL.

You will lead complex cross-functional programs from concept to commercialization within medical device and combination products, guiding strategy, planning, budgeting, and risk management across the lifecycle. You will coordinate IND/BLA activities and work with Regulatory, Quality, Clinical, and Manufacturing teams to align device and biologics strategies, ensuring successful program delivery