Regulatory Affairs Specialist jobs in Terre Haute, IN

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)

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Regulatory Affairs Specialist
  • NuVasive, Inc.
  • Brazil, IN FULL_TIME
  • Job Summary and Primary Responsibilities

    Coordinates and prepares document packages for regulatory submissions for new and mature products. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications. 

    • Documents appropriate regulatory strategies for new products and initiates necessary activities by working with various functional teams as needed
    • Assists with product submissions globally, remaining current with local regulation changes
    • Supports cross-functional teams by providing appropriate regulatory procedures for new projects
    • Reviews regulatory requirements from other departments for new product designs or changes to existing designs 
    • Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
    • Organizes all regulatory pre-market submissions and other pre-market filings to ensure appropriate commercial distribution clearances are acquired
    • Supports product import by providing applicable regulatory documentation and certificates
    • Performs other duties as assigned

     

    Required Skills / Capabilities
    • Basic understanding of regulatory requirements throughout the product lifecycle
    • Understanding of regulatory terminology, pre-market submission types, and requirements
    • Able to evaluate regulatory impact of proposed product and process changes
    • Multi-tasking skills with the ability to project plan and meet deadlines
    • Result driven with a sense of responsibility, urgency and ability to perform under pressure
     
    Education and Experience

    ·       Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience

       
    Travel and/or Physical Requirements

    n/a


    For roles that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).



    NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here. NuVasive's EEO policy is available here
     
    About NuVasive
    NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.
  • 1 Month Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Terre Haute, IN 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...
  • 11 Days Ago

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Administrative Assistant for the Office of Student Affairs
  • Rose-Hulman Institute of Technology
  • Terre Haute, IN FULL_TIME
  • Administrative Assistant for the Office of Student Affairs Rose-Hulman Institute of Technology has a great opportunity for individuals excited and committed to lifelong learning and enriching the live...
  • 10 Days Ago

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SPECIALIST
  • HCL Technologies
  • Brazil, IN FULL_TIME
  • Linux/UnixCloud provisioning tools, preferably TerraformCI/CD and devops tools like Jenkins, Artifactory, Docker, VaultDevelopment experience with Python/Go/GroovyTriage and support system application...
  • 7 Days Ago

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Billing Specialist
  • Wabash Valley Health Center
  • Terre Haute, IN FULL_TIME
  • STATUS: Full-time Monday - Friday DESCRIPTION: Wabash Valley Health Center has an opening for a Billing Specialist. This person will be responsible for billing of patient and insurance balances. This ...
  • 21 Days Ago

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Loan specialist
  • Fifth Third
  • Terre Haute, IN FULL_TIME
  • Make banking a Fifth Third better We connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank. GENERAL FUNCTION : Performs a w...
  • 21 Days Ago

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0 Regulatory Affairs Specialist jobs found in Terre Haute, IN area

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Certified Occupational Therapist Assistant - COTA
  • Intrepid USA Health Care Services
  • Terre Haute, IN
  • Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall 50 year h...
  • 3/28/2024 12:00:00 AM

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Hospice Aide
  • Intrepid USA
  • Terre Haute, IN
  • Overview: Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall...
  • 3/27/2024 12:00:00 AM

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Care Team Manager
  • Intrepid USA
  • Terre Haute, IN
  • Overview: Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall...
  • 3/26/2024 12:00:00 AM

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Manufacturing Technology Engineer
  • IFF Family of Companies
  • Terre Haute, IN
  • Requisition ID : 497014 Job Description At IFF, the heart of our company is fueled by a sense of discovery, constantly a...
  • 3/25/2024 12:00:00 AM

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Hospice Aide - Hiring Now!
  • Intrepid USA
  • Terre Haute, IN
  • Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall 50 year h...
  • 3/20/2024 12:00:00 AM

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Registered Nurse / RN - Home Health - PRN - Hiring Now!
  • Intrepid USA
  • Terre Haute, IN
  • Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall 50 year h...
  • 3/19/2024 12:00:00 AM

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Care Team Manager - Hiring Now!
  • Intrepid USA - Glassdoor ✪ 3.6
  • Terre Haute, IN
  • Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall 50 year h...
  • 1/19/2024 12:00:00 AM

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Registered Nurse / RN - Home Health - Full Time - Hiring Now!
  • Intrepid USA
  • Terre Haute, IN
  • Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall 50 year h...
  • 1/19/2024 12:00:00 AM

Terre Haute is located alongside the eastern bank of the Wabash River in western Indiana. The city lies about 75 miles (121 km) west of Indianapolis. According to the 2010 census, Terre Haute has a total area of 35.272 square miles (91.35 km2), of which 34.54 square miles (89.46 km2) (or 97.92%) is land and 0.732 square miles (1.90 km2) (or 2.08%) is water. The Wabash River dominates the physical geography of the city, forming its western border. Small bluffs on the east side of city mark the edge of the historic flood plain. Lost Creek and Honey Creek drain the northern and southern sections ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$69,499 to $93,139
Terre Haute, Indiana area prices
were up 1.3% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020