Senior Medical Device Program Lead for Development & Launch

BioTissue; Miami (FL); Presencial; USD 124.000 - 156.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, and Vision Insurance

Health Savings Account (HSA) and FSA

401(k) Retirement Savings Plan

Paid Time Off

Descripción de la vacante

BioTissue is seeking a Senior Technical Program Manager to lead complex cross-functional product development programs from concept through commercialization within medical device and/or combination product programs. This role coordinates regulatory, clinical, quality, and engineering teams to align development with regulatory expectations and business goals.

Responsibilities include developing integrated plans, managing risk, and driving program milestones across the lifecycle, including IND/BLA

Formación

• 8+ years of experience in regulated product development, technical operations, CMC, engineering or related life sciences environment.
• 5+ years leading cross-functional product development projects or programs with plans, risks, budgets, resources, governance.
• Experience supporting biologics development and an IND/BLA submission; medical device or combo product experience advantageous.
• Knowledge of FDA regulations (21 CFR Part 820/211/212, etc.), ICH guidelines, cGMP, ISO 13485/14971, device design controls, and QBD.

Responsabilidades

• Lead complex cross-functional product development programs through concept to commercialization.
• Develop and maintain integrated plans, schedules, budgets, resources, and dependencies.
• Coordinate stage-gate design reviews and prepare concise decision packages.
• Manage risk across technical, regulatory, quality, and clinical workstreams.
• Coordinate external labs, CROs, CMOs, and other development partners.
• Ensure alignment with business cases, portfolio priorities, and milestones.

Conocimientos

Regulated dev

Stage-gate governance

Design controls

Quality by Design

Risk management

Verification & validation

Technology transfer

Commercialization readiness

Educación

Bachelor's degree

Advanced degree preferred

Descripción del empleo

BioTissue is seeking a Senior Technical Program Manager to lead complex cross-functional product development programs from concept through commercialization within medical device and/or combination product programs. This role coordinates regulatory, clinical, quality, and engineering teams to align development with regulatory expectations and business goals.

Responsibilities include developing integrated plans, managing risk, and driving program milestones across the lifecycle, including IND/BLA