Regulatory Affairs Specialist

Mansfield, MA, us on site Until 8/21/2026 H-1B sponsor history First posted February 23, 2026 Last posted February 23, 2026
Job description

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.

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 

To know more about the position or to schedule an interview, please contact:

Sagar.rathore(at) collabera.com

630-485-2166

About this role

Summary

Prepare, review, and audit technical files and design dossiers for medical devices.

Job title

Regulatory Affairs Specialist

Experience level

not specified

Industry

healthcare

Location requirements

Mansfield, MA, US; remote not specified

Salary

Not specified

Visa sponsorship

H-1B sponsor history

Management role

No

Skills & keywords

Required skills

knowledge of US regulationsknowledge of European/International standardstechnical filesrisk management

Preferred skills

None specified

Specializations

medical devicestechnical filesrisk managementregulations
Locations

Structured locations inferred from the posting.

Mansfield, MA, USA

On-site City