Propharmagroup
Project Manager - Class III Medical Implants
United States · Mid
Sponsorship not specifiedDetected 30 days ago
Product ManagementProject ManagementSupply ChainClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCommunication
About the role
- The Project Manager for Class III Medical Implants is responsible for leading cross‑functional teams through the full lifecycle of highly regulated, risk‑critical medical device programs.
- Stakeholder & Communication Management - Communicate project status, milestones, risks, and decision needs to executives and key stakeholders. - Serve as the primary point of contact for project-related inquiries.
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
Responsibilities
- Lead end‑to‑end project management from concept through design, verification/validation, clinical evaluation, regulatory submission activities including PMA preparation, IDE clinical studies, and global regulatory pathways (FDA, EU MDR) where applicable.
- Develop and maintain integrated project plans, schedules, budgets, and risk registers.
- Manage project KPIs, timelines, and resource allocations
- Design & Development Oversight
- Drive implementation of design controls compliant with 21 CFR 820, ISO 13485, and ISO 14971 risk management requirements: user needs, design inputs/outputs, verification, validation, design transfer.
- Collaborate with engineering teams to ensure design requirements are met for implantable use (biocompatibility, sterilization, packaging, durability).
- Partner with operations/manufacturing teams to develop scalable, validated production processes.
- Support process validation (IQ/OQ/PQ) and device master record (DMR) creation.
- Manage project KPIs, timelines, and resource allocations; escalate risks proactively.
- Drive implementation of design controls compliant with 21
Requirements
- Support planning and execution of clinical studies or physician evaluations when required.
- Experience in cross‑functional leadership and complex product development.
- Education
- Experience
- 5+ years of project management experience in medical devices
- Class III or implantable medical device development experience strongly preferred, including PMA or IDE programs.
- Demonstrated familiarity with regulatory frameworks for high‑risk medical devices.
- Skills & Competencies
- Deep understanding of design controls, risk management, and medical device quality systems.
- Ability to manage ambiguity and drive decision‑making.
Nice to have
- Bachelor's degree required (Engineering, Life Sciences, or related field preferred).
- Master's degree or PMP certification a plus.
Skills
- Excellent organizational and planning skills.
- Strong interpersonal and communication skills.
- Expertise using project management tools (MS Project, Smartsheet, or similar).
Benefits
- We are committed to diversity, equity, and inclusion.
Equal opportunity
- With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
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