Regulatory Affairs Specialist jobs in Fort Myers, 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

• Lead and manage day to day activities and corporate APAC regulatory staff;
• Support regulatory activities that lead to and maintain regulatory compliance and approval for Arthrex devices in APAC;
• Work closely with regional APAC regulatory team to develop and drive process efficiencies for APAC regulatory submissions;
• Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives;
• Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory documentation for new products, amendments of approved products, and submissions that support the maintenance of existing licenses;
• Support in implementation of policies, procedures, practices, and strategies to facilitate support of in-country product registrations in APAC;
• Review and evaluate issues that may create regulatory or business obstacles, and propose solutions;
• Monitor APAC regulations/guidelines and the impact of changing/evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders.
• Manage the performance and career development of direct reports.

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 2023 Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

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.