A global medical device company and a leader in new product development and medical education in orthopedics is actively seeking a GCP QA Specialist – Principal to work directly with the Engineering & Clinical Research departments within Arthrex to ensures that all activities are performed in accordance with all Good Clinical Practices (GCPs), company policies, and applicable regulations to provide timely delivery of high-quality clinical data to support global registration and commercialization of company products. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree & 10 years of experience in a Clinical Quality, Regulatory, or Clinical-adjacent role will be essential for this position.
Essential Duties and Responsibilities:
Leads in the development of Quality (GCP) program for Clinical Research Team.
Navigates and communicates the Clinical Regulatory landscape of multiple regions as appropriate to Medical Devices, Biologic products, and medical consumables.
Maps current Clinical Research processes, reviews existing essential documentation, creates and implements plans for gap closure.
Collaborates with Clinical Research Team on educational initiatives to develop GCP content and train Arthrex personnel.
Reviews Clinical Investigation Plans for adherence to procedural requirements and GCPs.
Compiles and distributes information supporting GCP impact for prospective, ongoing, and completed studies related to the Regulatory Status of Arthrex Product.
Collaborates with Clinical Research Team to Audits prospective Clinical research Organizations to determine Supplier Qualification.
Liaises with Regulatory Affairs and Quality in-country partners to assess risk and support the development of OUS Quality programs.
Verifies and keeps metrics related to the effectiveness of completed changes and risk mitigation activities and appropriately supports remediation activities.
Communicates effectively with internal and external business partners, including Orthopedic Research, Regulatory Affairs, Product Management, Engineering, Quality, IT, and other functions as appropriate to achieve the company quality objectives.
Professionally communicates critical time-sensitive information, exceptions, and changes to affected parties.
Participates in audits and inspections of Clinical Research activities.
The above statements describe the general nature and level of work performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s degree required.
Ten (10) years of experience in a Clinical Quality, Regulatory, or Clinical-adjacent role within the regulated industry (Medical Device, Pharma, or Biotech) required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Thorough knowledge of US FDA Code of Federal Regulations (21 CFR 11, 50, 54, 56, 812, 814), (EU) 2017/745, International Conference on Harmonization (ICH) and International Standards Organization (ISO) 14155:2020, 13485:2016, 14971:2019 is required.
Clinical Research Certification or Quality Certification is required OR obtained in one year.
Comprehension of medical terminology, or can reference literature for understanding.
Proficient software skills: Word/ Excel/ Power Point/database.
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools.