Collabera

Regulatory Affairs Specialist

Reposted 16 Days Ago

Be an Early Applicant

In-Office

Mansfield, MA

Mid level

In-Office

Mansfield, MA

Mid level

Manage regulatory affairs by preparing, reviewing, and auditing medical device documentation, including Technical Files and Risk Management files.

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Company 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.

Job Description

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

Top Skills

Design Dossiers

Medical Device Regulations

Risk Management

Technical Files

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