Regulatory Affairs Specialist
AI Summary
Regulatory Affairs Specialist prepares, reviews, and audits medical device regulatory files including DHFs, Risk Management files, and DMRs, ensuring compliance with European/International and US regulations.
About this role
Regulatory Affairs Specialist
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Regulatory affairs with Technical Files, or equivalent in an R&D or quality position with hands-on experience in the preparation, review, and/or auditing of medical device DHFs, Risk Management files, and/or DMR’s.
Qualifications
Must have knowledge of European/International and US regulations and standards; Experience in preparing and content of technical files and design dossiers; Experience with preparation, review, and/or auditing
Additional Information
To know more about the position or to schedule an interview, please contact:
Sagar.rathore(at) collabera.com
630-485-2166
Skills
Explore related jobs
More jobs at Collabera
Browse these categories
Market data for this role
All reports →- SeriesRole reportsOne role family at a time: how many openings, what changed this week, who is hiring, what it pays.
- SeriesSalary reportsWhat employers publish in job postings, by level and workplace. Not self-reported pay.
- Market overviewState of tech hiring, September 2026: up 4.8%Tech hiring rose 4.8% month over month in September 2026, with 411,122 new listings. Customer support and account executive roles led the growth.