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Regulatory Affairs & Quality Systems Manager

Company: OrthoPediatrics
Location: Wayland
Posted on: June 24, 2022

Job Description:

OrthoPediatrics is looking for a Regulatory Affairs & Quality Systems Manager for our wholly-owned subsidiary - MD Orthopaedics, based in Wayland, Iowa:
The Regulatory Affairs/QMS Manager will serve as the process Leader for the world's leading manufacturer and distributor of clubfoot products. The ideal candidate will be an entrepreneur with proven experience in international regulatory and quality system development and compliance, risk management, process improvement, and change management in a leadership capacity. Strong skills in communications, change management, lean high-performance leader.
This is a key leadership role in supporting the transition from a successful family business into a high growth global leader in our niche. This position will lead the team in providing regulatory and quality system leadership and in developing and implementing business strategy, risk management, and marketing of medical products. -
Leadership Responsibilities:

  • Manage global compliance for Class 1 medical devices
  • Responsible for leading an ISO13485 compliant medical device manufacturer
  • Responsible for International product registrations (FDA, MDR, Health Canada, ROW)
  • Accountable for International importer & distributor RA/QA due diligence
  • Lead Management Review and support post market surveillance
  • Define Foreign product registrations requirements
  • SME on regulatory strategy for new product development
  • Collaborate with all levels of MDO staff members in the implementation of QMS and in training staff
  • SME/advisor to product development team for all NPD programs (technical files, product registration, validation, etc.)
  • SME for all product technical communications (IFU), labelling, and product packaging in collaboration with product management and marketing communication teams
  • Lead, coach, and mentor a culture which embraces the changes required to sustain the highest product quality, lowest cost structure, and creating competitive advantages in our niche
  • Manage company-wide medical device legal compliance and training for Anti-Kickback, Sunshine Act, Foreign Corrupt Practices, etc. - work closely with GM and with company legal advisors and consultants
    • Demonstrated leadership of cross functional regulatory, quality management systems, business process, compliance discipline, skills, and capabilities within a high performing business culture
    • Advanced level of knowledge and skills required to work effectively, maintain compliance with best-in-class process discipline for Class 1 medical devices as defined above
    • Proven experience implementing process improvement initiatives
    • Proven ability to build and manage high-performance teams to execute plans on time within budget
      Education and/or Experience
      • 4-year degree in bio-medical engineering
      • Minimum of 10 years prior RA/QA experience
      • Minimum 7 years medical device experience
      • Advanced experience with FDA 510(k) submission
      • Advanced experience with ISO 13485 and EU MDR for CE Marking
      • 5+ years orthotics & prosthetics (O&P) experience preferred

Keywords: OrthoPediatrics, Cedar Rapids , Regulatory Affairs & Quality Systems Manager, Executive , Wayland, Iowa

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