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Regulatory Affairs Specialist

NuVasive, Inc.
Brazil, IN Full Time
POSTED ON 2/21/2024
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.

Salary.com Estimation for Regulatory Affairs Specialist in Brazil, IN
$82,824 to $110,146
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