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.
Asian Regulatory Affairs, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
4 Year Degree
Supports Regulatory Affairs activities for Arthrex, Inc.
Essential Duties and Responsibilities:
Prepares, writes and submits regulatory filings
Completes product registration activities
Gathers information and data from other departments and external resources for regulatory submissions
Reviews and approves advertising and promotional materials
Develops regulatory strategy
Performs technical and scientific regulatory activities
Participates in regulatory or quality systems audits as required
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:
Bachelor’s degree required.
7 years direct experience and training in regulatory affairs.
Strong interpersonal, oral and written communication skills required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Interpersonal and communication skills
Proficient in one other language preferred
Proficient in Microsoft Office
Ability to work in fast paced environment
Strong written communication skills
Ability to independently manage multiple projects over extended periods of time
Internal and external communication and collaboration skills
Subject Matter Expert for at least one region or product type
Advanced understanding of regulatory framework and regulatory requirements for multiple regions
Comprehensive understanding of orthopedic technical/ engineering/medical terminology preferred
Knowledge of product lifecycle
Knowledge of Asia regulatory affairs is preferred
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools.
Internal Number: 43234
About Arthrex, Inc.
We are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, we have pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.
We continue to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.