Regulatory Affairs Specialist jobs in Cape Coral, FL

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

A
Manager, Regulatory Affairs - Asia Pacific
  • Arthrex
  • Naples, FL FULL_TIME
  • Date: Oct 27, 2023

    Location: Naples, FL, US, 34108

    Company: Arthrex

    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

    • 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.

  • 20 Days Ago

F
Regulatory specialist
  • Florida Forest Service
  • Immokalee, FL FULL_TIME
  • MINIMUM REQUIREMENTS : A bachelor’s degree from an accredited college or university. Professional or nonprofessional experience in administrative work, regulatory work, consumer complaint program work...
  • 27 Days Ago

S
Regulatory specialist
  • State of Florida
  • Fort Myers, FL FULL_TIME
  • Requisition No : 823099 Agency : Department of Health Working Title : OPS REGULATORY SPECIALIST II - 64800685 Pay Plan : Temp Position Number : 64800685 Salary : $15.00 per hour Posting Closing Date :...
  • 1 Month Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Fort Myers, FL FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Naples, FL FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

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68025178 - REGULATORY SPECIALIST I
  • State of Florida
  • FORT MYERS, FL FULL_TIME
  • Requisition No: 811875 Agency: Agency for Health Care Administration Working Title: 68025178 - REGULATORY SPECIALIST I Position Number: 68025178 Salary: $1,260.00 Biweekly Posting Closing Date: 04/08/...
  • Just Posted

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0 Regulatory Affairs Specialist jobs found in Cape Coral, FL area

A
Social Services Assistant
  • Aspire on Santa Barbara
  • Cape Coral, FL
  • Aspire on Santa Barbara - Looking for qualified Social Services Assistant to join our family! We are searching for a Soc...
  • 3/28/2024 12:00:00 AM

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Branch Manager (SAFE) - Merchants Crossing
  • Wells Fargo & Co.
  • Cape Coral, FL
  • **Branch Manager (SAFE) - Merchants Crossing** Location: Cape Coral, Florida **Job ID** R-117586 **About this role:** We...
  • 3/28/2024 12:00:00 AM

M
Medication Technician - All shifts available!
  • Meridian Senior Living
  • Cape Coral, FL
  • Meridian Senior Living believes that "Everyone Deserves a Great Life." To us, a great life in our communities starts wit...
  • 3/28/2024 12:00:00 AM

C
Plant Mechanic
  • City of Fort Myers, FL
  • Fort Myers, FL
  • Salary: $22.26 Hourly Location : Fort Myers, FL Job Type: Full-Time Job Number: 24-01010 Department: Water Treatment Pla...
  • 3/28/2024 12:00:00 AM

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Registered Nurse / RN Cardiology Progressive Care - 2W PT Nights
  • Lee Health
  • Fort Myers, FL
  • Location:HealthPark Medical Center -9981 So HealthPark CircleFort Myers FL 33908 Department: 2W Cardiology Work Type: Fu...
  • 3/28/2024 12:00:00 AM

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RN Infection Preventionist (ADON)
  • Ambassador Healthcare at College Park
  • Fort Myers, FL
  • Ambassador Healthcare at College Park - Company: Ambassador Healthcare at College Park Salary: $42 per hour About Us: Am...
  • 3/28/2024 12:00:00 AM

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Associate Personal Banker South Venice
  • WELLS FARGO BANK
  • Venice, FL
  • Job Description Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company ...
  • 3/27/2024 12:00:00 AM

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Senior Construction Inspector / Capital Improvement Program / City Manager #7918
  • City of Cape Coral, FL
  • Cape Coral, FL
  • Salary : $46,113.60 - $87,713.60 Annually Location : CITY OF CAPE CORAL, FL Job Type: Full-Time Regular Job Number: 0791...
  • 3/25/2024 12:00:00 AM

Cape Coral /ˈkɒrəl/ is a city located in Lee County, Florida, United States, on the Gulf of Mexico. Founded in 1957 and developed as a planned community, the city grew to a population of 154,305 by the year 2010. The city's population estimate was 165,831 for 2013 and 179,804 for 2016. With an area of 120 square miles (310 km2), Cape Coral is the largest city between Tampa and Miami. It is a principal city in the Cape Coral – Fort Myers, Florida Metropolitan Statistical Area. The population estimate for the statistical area was 679,513 for 2014. The city is known as a "Waterfront Wonderland";...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$70,845 to $94,942
Cape Coral, Florida area prices
were up 1.5% from a year ago

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