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
Qualifications
- 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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