Regulatory Relations Specialist jobs in Terre Haute, IN

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (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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Community Relations Manager
  • MOSAIC
  • Terre Haute, IN FULL_TIME
  • Kick start the year with a new adventure and take your career to new heights! If making a positive impact in the lives of others is a constant on your to-do list — you’ll LOVE working with a team that...
  • 26 Days 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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Community Relations Manager - Terre Haute, IN
  • Mosaic
  • Terre Haute, IN FULL_TIME
  • City Terre Haute Description Kick start the year with a new adventure and take your career to new heights! If making a positive impact in the lives of others is a constant on your to-do list - you'll ...
  • Just Posted

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Associate Director of Athletics, Communications, & Public Relations
  • Rose-Hulman Institute of Technology
  • Terre Haute, IN FULL_TIME
  • Associate Director of Athletics, Communications, & Public Relations Rose-Hulman Institute of Technology has an amazing opportunity for individuals excited and committed to lifelong learning and being ...
  • 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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0 Regulatory Relations 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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FedEx - Terre Haute, IN Road Driver
  • CDL Training Today
  • Terre Haute, IN
  • **Now Hiring CDL-A Road Drivers in Terre Haute, IN!** **Home Daily - Starting Pay $0.5815/Mile - Excellent Benefits!** F...
  • 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

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 Relations Specialist jobs
$68,151 to $93,559
Terre Haute, Indiana area prices
were up 1.3% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020