CONMED Corporation · 20 hours ago
Specialist Regulatory Affairs - Denver, CO
Denver, CO
Full-time
Onsite
New Grad, Entry Level
$67K/yr - $97K/yrCONMED Corporation is seeking a Regulatory Affairs Specialist to assist the RA team with product registrations for domestic and international markets. The role involves compiling necessary documentation for regulatory compliance and supporting the submission processes for FDA and other international registrations.
Information TechnologyMedicalMedical Device
No H1B
Responsibilities
Assist in executing product registrations for USFDA submission (510(k), CE-mark certificate and other international registrations, which includes creating and maintaining Technical Files and supportive documents
Prepare global regulatory files/submissions for product registration as assigned
Assist in the review of proposed design changes and ECOs to assess regulatory impact
Assemble information required for domestic and international submissions
Assist the Specialists in assembly and update of Technical Files and Dossiers
Provide timely review of product labeling for regulatory compliance
Compile information for Medical Device Listings and Certificates to Foreign Government
Research and compile information required for customs and sales force requests
Assist as needed with marketing collateral reviews
Perform other related duties and special projects as required by management
Qualification
Required
Bachelor's Degree in science, engineering or related field
Knowledge of regulatory, quality or similar position
Ability to execute assignments independently as assigned
Must possess strong organization skills
Must possess strong written and verbal communication skills
Demonstrated ability to handle multiple priorities simultaneously
Preferred
M.S. in a technical field or MBA preferred
Additional Regulatory certifications preferred
Experience within the Medical Device industry preferred
Experience with 510(k) and EU technical documentation preferred
Benefits
Competitive compensation
Excellent healthcare including medical, dental, vision and prescription coverage
Short & long term disability plus life insurance -- cost paid fully by CONMED
Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
Employee Stock Purchase Plan -- allows stock purchases at discounted price
Tuition assistance for undergraduate and graduate level courses
Company
CONMED Corporation
CONMED is a global medical technology company that specializes in the development and sale of surgical and patient monitoring products and services that allow our physician customers to deliver high quality care and as a result, enhanced clinical outcomes for their patients.
Founded in 1970
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$700M2022-05-31Post Ipo Debt· $700M
2012-07-16Acquired
2003-01-01Post Ipo Equity
Leadership Team
Patrick Beyer
Chief Executive Officer
Todd Garner
EVP, CFO
Recent News
2026-01-09
Yahoo Finance
2025-12-08
Company data provided by crunchbase