Skip to main content
Tallo logoTallo logo
Apply for this opportunity

This job application is on an outside website. Be sure to review the job posting there to verify it's the same.

Apply Offsite

Pre Market Regulatory Affairs Specialist

Job

GxPartners

Indianapolis, IN (In Person)

$85,000 Salary, Full-Time

Posted 1 week ago (Updated 2 days ago) • Actively hiring

Expires 7/12/2026

Review key factors to help you decide if the role fits your goals.
How is this calculated?
Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
73
out of 100
Average of individual scores

Were these scores useful?

Skill Insights

Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.

Job Description

RA Specialist Objective:
Obtain establishment/product registration approval in desired markets to ensure the license to sell. Provide support for regulatory functions.
Responsibilities and Essential Functions:
Prepare, update, and maintain regulatory documentation to support global submissions, including FDA device listings, Health Canada Medical Device Licenses, EU technical documentation, and other market registrations. Review and approve product labeling, CERs, PMS Plans, PSURs, packaging, and Instructions for Use (IFUs) for regulatory compliance across key markets. Maintain regulatory databases such as FDA FURLS/GUDID, Health Canada listings, and EUDAMED, ensuring timely and accurate updates. Support change control and product lifecycle management activities by providing regulatory impact assessments and guidance. Maintain organized and inspection-ready regulatory files, correspondence, and submission archives. Collaborate with Quality, R&D, Marketing, and Supply Chain to ensure regulatory alignment on product changes, risk documentation, and labeling content. All other duties as assigned.
Qualifications:
Bachelor's degree in Life Sciences, or a related technical discipline required. Minimum 3 years of experience in regulatory affairs within the medical device industry or related industry, with direct involvement in U.S. FDA, Health Canada, and EU regulatory submissions and maintenance activities. Experience contributing to 510k FDA submissions preferred. Proven experience reviewing and approving labeling, packaging, and Instructions for Use (IFUs). Familiarity with CERs, PSURs, MDRs, and risk management activities preferred. Proficiency with regulatory and document management systems (e.g., Agile, or equivalent) and regulatory authority portals. Comprehensive understanding of global medical device regulatory frameworks and relevant ISO standards.
Pay:
$70,000.00 - $100,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off
Work Location:
In person