Posted in General Business about 2 hours ago.
Type: Full-Time
Location: Naples, Florida
Requisition ID: 59200 Title: Manager, Regulatory Affairs - Asia Pacific Division: Arthrex, Inc. (US01) Location: Naples, FL
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Manager, Regulatory Affairs - Asia Pacific who is responsible for leading a team of Regulatory Specialists that comprise the corporate APAC (Asia Pacific) regulatory team at the Arthrex headquarters in Naples, Florida. This position is responsible for the corporate regulatory support for in-country product registrations in the APAC region through collaboration with various functions within the company as well as regional Regulatory teams. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Duties and Responsibilities
Education and Experience:
Bachelor's degree required.
Advanced Degree (MS or PhD, or equivalent) preferred; preferably in a Science or Engineering discipline.
5 years direct experience in Regulatory Affairs in a Medical Device Company required. Orthopedics preferred
3 years management experience required
Training in technical aspects of regulatory affairs required
Regulatory experience in U.S. required, OUS experience is highly desirable
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Strong interpersonal and communication skills
Proficient in Microsoft Office
Ability to work in fast paced environment
Advanced written communication skills
Ability to plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
Internal and external communication and collaboration skills
Knowledge and experience in business, supervision, and management
Ability to lead, develop, and effectively manage employees
Strong interpersonal relationship building and employee coaching/ development skills
Reasoning Ability:
Ability to think critically and propose multiple solutions to solve problems. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Vision Requirements:
Visual acuity necessary to do the job safely and effectively.
Specific vision abilities required by this job include close vision.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.
Arthrex Benefits
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
Arthrex, Inc.
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Arthrex, Inc.
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