Director, Post Market (Medtech)

TL;DR

Director, Post Market (Medtech): Develops and leads a Quality Assurance team managing post-market QMS processes, including surveillance, product correction, complaint management, and vigilance reporting with an accent on ensuring compliance with medical device regulations. Focus on managing communication with regulatory agencies and driving improvements in process efficiencies.

Location: Onsite in Gainesville, FL

Company

hirify.global focuses on innovation in orthopedic implants and instruments to improve efficacy and outcomes.

What you will do

• Develop, lead, and direct a Quality Assurance team managing key post-market QMS processes.
• Identify and resource improvement programs to ensure compliance with medical device regulations and standards.
• Oversee the collection, analysis, and reporting of post-market quality signals.
• Manage communication with the FDA and international regulatory agencies for post-market surveillance activities.
• Lead key QMS projects that drive improvements in process efficiencies and effectiveness.
• Provide guidance and training of GMP requirements to company employees.

Requirements

• Bachelor’s Degree in a related field required; Master’s Degree preferred.
• Minimum 10 years’ experience in FDA/ISO medical devices or equivalent quality management system regulations required.
• Minimum 5 years experience technical writing skills for healthcare, science or quality management systems required.
• Working knowledge of windows-based office productivity tools.
• Excellent verbal and written communication skills.
• Knowledge of CFR Part 820 Medical Device Quality System Regulations, CFR Part 806, CFR 803 and ISO 13485:2016 requirements.

Nice to have

• RN or similar healthcare certification preferred.

Culture & Benefits

• Focused on innovation in orthopedic implants and instruments.
• Committed to improving efficacy and outcomes for patients.
• Values collaboration and continuous improvement.