About ProPharma
For over 20 years, ProPharma has enhanced patient health and wellness by providing expert consulting to biotech, medical device, and pharmaceutical organizations. Through its advise–build–operate model, the company supports clients across the full product lifecycle.
Core Expertise
Regulatory Sciences
Clinical Research Solutions
Quality & Compliance
Pharmacovigilance
Medical Information
R&D Technology
ProPharma delivers customizable, end-to-end solutions designed to reduce risk and accelerate drug and device development.
Role Overview
Position: Project Manager – Class III Medical Implants
This role is responsible for leading cross-functional teams through the full lifecycle of high-risk, highly regulated implantable medical device programs. The Project Manager ensures projects are delivered on time, within budget, and in compliance with global regulatory requirements.
Key Responsibilities
1. Project Leadership & Execution
Lead end-to-end project management from concept to commercialization
Oversee:
Design & development
Verification & validation
Clinical evaluation
Regulatory submissions (PMA, IDE, global pathways including FDA & EU MDR)
Develop and manage:
Project plans, timelines, and budgets
Risk registers and mitigation strategies
Facilitate cross-functional team meetings (R&D, Quality, Regulatory, Manufacturing, Clinical, Marketing)
Track KPIs, resource allocation, and timelines
Proactively identify and escalate risks
2. Design & Development Oversight
Ensure compliance with:
21 CFR Part 820
ISO 13485 (Quality Management Systems)
ISO 14971 (Risk Management)
Drive implementation of design controls:
User needs
Design inputs/outputs
Verification & validation
Design transfer
Collaborate with engineering teams on implant-specific requirements:
Biocompatibility
Sterilization
Packaging
Durability
Support clinical studies and physician evaluations as needed
3. Manufacturing & Supply Chain Coordination
Partner with manufacturing teams to establish scalable production processes
Ensure supplier compliance with regulatory and quality standards
Support:
Process validation (IQ/OQ/PQ)
Device Master Record (DMR) development
4. Stakeholder & Communication Management
Communicate project progress, milestones, and risks to leadership
Act as the primary point of contact for project-related matters
Drive decision-making and stakeholder alignment
Qualifications
Education
Bachelor’s degree required (Engineering, Life Sciences, or related field preferred)
Master’s degree or PMP certification is a plus
Experience
5+ years of project management experience in medical devices
Strong experience with Class III or implantable medical devices preferred
Experience with PMA and/or IDE programs
Familiarity with global regulatory frameworks for high-risk devices
Proven experience leading cross-functional teams
Skills & Competencies
Strong knowledge of:
Design controls
Risk management
Medical device quality systems
Excellent organizational and planning skills
Strong communication and interpersonal abilities
Ability to manage ambiguity and drive decisions
Proficiency with project management tools (e.g., MS Project, Smartsheet)
Work Arrangement
Remote work with approximately 20% onsite presence in Effingham, Illinois
Hybrid work encouraged for employees near office locations
Work Culture & Inclusion
Commitment to diversity, equity, and inclusion
Encourages innovation, collaboration, and entrepreneurial thinking
Equal Opportunity Employer providing an inclusive work environment
Recruitment Process
Applications reviewed by human recruiters (no AI screening)
All applicants receive a response regarding their application
Additional Notes
Remote flexibility with encouragement for in-person collaboration when feasible
No advantage or disadvantage based on proximity to office
No unsolicited resumes from third-party recruiters
No phone calls or emails regarding this posting
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