
Specialist, Regulatory Affairs
Plans, assigns and manages regulatory affairs activities for projects within assigned business unit(s) in order to meet deadlines. Supervises Regulatory Affairs Specialists, prepares and submits performance reports, sets performance goals, recommends on-the-job training, courses, seminars, etc., and decides on reward and promotion based on performance. Develops and/or conducts regulatory training for direct reports. Ensures direct reports understand their duties or delegated tasks and monitors productivity, providing constructive feedback and coaching. Ensures policies, practices and procedures are understood and followed by direct reports. Reports to manager the status of projects and other relevant information on a timely basis. Identifies and communicates information to manager which would affect regulatory compliance within the assigned business units. Assists in the implementation of team initiatives/plans as specified by manager.
7 Years experience in a regulatory affairs role in the medical device industry required, orthopedics preferred.
Advanced degree preferred.
Regulatory Affairs Certification (RAC) preferred
Clinical or statistical experience preferred.
Ability to identify and assess business risks for a given Regulatory strategy.
Adobe
Time Management
Project Management Skills
MS Word
Technical writing skills
MS Excel skills
Product development process
Process Improvement
Verbal communication
written communication
Adaptability
Detail Oriented and Organized
According to JobzMall, the average salary range for a Specialist, Regulatory Affairs in 1951 J and C Blvd, Naples, FL 34109, USA is $123,000 - $137,000. This range may vary depending on the experience level and qualifications of the individual.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
Arthrex, an orthopedic medical device company, is a leader in product development, medical education and a pioneer in arthroscopy, having developed thousands of products and surgical procedures in orthopedic medicine worldwide.

Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started