Demo

Regulatory Affairs Specialist

Astrix
Fort Worth, TX Full Time
POSTED ON 1/13/2025 CLOSED ON 2/8/2025

What are the responsibilities and job description for the Regulatory Affairs Specialist position at Astrix?

Exciting 2 year development contract onsite opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.


Regulatory Affairs Specialist I

2 year contract

$40.00-$45.52 per hour

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU and Canada submissions).
  • Communicate with internal stakeholders regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Conduct regulatory impact assessment for post approval changes and support preparation of necessary submission documentation
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Write or update standard operating procedures, work instructions, or policies.


Education:

  • Bachelor's Degree - no specific Field of study.
  • Experience with Regulatory Affairs U.S., EU and Canada Submission


This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Salary : $40 - $46

Entry Level Manufacturing Regulatory Affairs Specialist
Texas Refinery Corp -
Mansfield, TX
Regulatory Affairs Manager
CSL Plasma -
Haltom, TX
Quality & Regulatory Affairs Analyst
InsideHigherEd -
Arlington, TX

If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Regulatory Affairs Specialist?

Sign up to receive alerts about other jobs on the Regulatory Affairs Specialist career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$78,084 - $104,270
Income Estimation: 
$95,800 - $126,196
Income Estimation: 
$97,803 - $128,184
Income Estimation: 
$95,508 - $129,349
Income Estimation: 
$77,272 - $101,684
Income Estimation: 
$95,800 - $126,196
Income Estimation: 
$97,803 - $128,184
Income Estimation: 
$95,508 - $129,349
Income Estimation: 
$95,800 - $126,196
Income Estimation: 
$122,529 - $166,597
Income Estimation: 
$123,229 - $164,502
Income Estimation: 
$123,155 - $167,827
Income Estimation: 
$122,529 - $166,597
Income Estimation: 
$185,828 - $247,157
Income Estimation: 
$140,918 - $196,956
Income Estimation: 
$166,245 - $219,788
Income Estimation: 
$66,241 - $89,540
Income Estimation: 
$77,272 - $101,684
Income Estimation: 
$78,084 - $104,270
Income Estimation: 
$75,043 - $100,052
This job has expired.
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at Astrix

Astrix
Hired Organization Address Rock Hill, SC Full Time
QC Lab Technician- 3rd Shift Shift: 3rd shift (Mon-Thurs 9p-7a) Summary The QC Lab Technician will perform wet chemistry...
Astrix
Hired Organization Address Monmouth, NJ Full Time
Document Control Specialist (Food Manufacturing) Location: Monmouth County, NJ Job Type: Full Time About the Role: We ar...
Astrix
Hired Organization Address Mercer, NJ Full Time
Our Client, a global leader in personal care and household products, is seeking a Lab Technician to join their growing t...
Astrix
Hired Organization Address Houston, TX Full Time
Our client is a leading biotech research company focusing on clinical research and developmental processes for new, life...

Not the job you're looking for? Here are some other Regulatory Affairs Specialist jobs in the Fort Worth, TX area that may be a better fit.

Regulatory Affairs Specialist I

eTeam, Inc., Fort Worth, TX

Source One Technical Solutions | Regulatory Affairs Specialist

Source One Technical Solutions, Fort Worth, TX

AI Assistant is available now!

Feel free to start your new journey!