The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Quality/Risk Management, Research & Development, US Regulatory Affairs
The position will mainly focus on developing Clinical Evaluation Reports (CERs), with potential for future additional responsibility for the development of other clinical evidence documents. The purpose of this job is to author and develop clinical evaluation reports (CERs) per MDR 2017/745 and MEDDEV 2.7.1 Rev 4, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.
Essential Duties and Responsibilities:
Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies and stay informed about applicable clinical landscapes and trends.
Combine an understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge to support Regulatory Affairs submissions for CE marking of new devices and maintaining CE marks for existing devices.
Extracts data from included studies, interpret study results, synthesizes literature, and prepares summaries into formal reports.
Organizes clinical data from literature into references, graphics, tables, and data listings
Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
Manage CER timelines required by product development teams and global regulatory bodies by utilizing the appropriate project management tools.
Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for the assigned project.
Ensure documents are produced per procedures, internal and external guidelines, and electronic templates
May author protocols and routine clinical study progress reports.
The above statements describe the general nature and level of work being 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:
Master’s degree required, preferably with a scientific emphasis.
PhD preferred or 5 years of documented scientific/research experience.
2 years experience in clinical evaluation report writing (CER) in the medical device industry is required.
Strong knowledge of orthopedic medical and surgical terminology
Experience writing study protocols and final study reports
Knowledge and Skill Requirements/Specialized Courses and Training:
Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)
Working knowledge of MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745
Working knowledge of ISO 14155.
Working knowledge of biomedical databases (i.e., Pubmed, Embase)
A thorough understanding of the National Library of Medicine’s Medical Subject Headings (MeSH)
Proficient in document development and management software skills: Word/ Excel/ PowerPoint.
Machine, Tools, and Equipment Skills:
Literature search tools, online meeting programs, citation manager software (EndNote)
PLEASE USE LINK BELOW TO APPLY ONLINE. ONLY CANDIDATES THAT SUBMIT ONLINE APPLICATIONS WILL BE CONSIDERED FOR EMPLOYMENT.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Incorporated since 1984, Arthrex has been a privately held corporation committed to just one thing: providing the finest quality products and educational services to meet the special needs of orthopaedic surgeons and their patients. Arthrex has a focused dedication to creative product development and medical education with an experienced, devoted team of professionals who are truly committed to continuing this tradition. New product innovation in arthroscopic surgery is the heart and soul of Arthrex, which has resulted in the development of over 6,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures. Our goal is to make technically demanding surgical procedures easier, safer and reproducible.Investing in Arthrex products means you have chosen a company committed to uncompromising quality and constant product innovation while providing you with the most competent technical customer support in the industry. Today our products are distributed throughout the U.S. and in over 60 countries worldwide.