Regulatory Affairs Specialist

Reposted 20 Days Ago
Be an Early Applicant
Mansfield, MA, USA
In-Office
Mid level
Information Technology • Software
The Role
Manage regulatory affairs by preparing, reviewing, and auditing medical device documentation, including Technical Files and Risk Management files.
Summary Generated by Built In
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

Skills Required

  • Knowledge of European/International and US regulations and standards
  • Experience with preparation and content of technical files and design dossiers
  • Hands-on experience in preparation, review, and/or auditing of medical device documents

Collabera Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Collabera and has not been reviewed or approved by Collabera.

  • Fair & Transparent Compensation Pay is considered acceptable to strong on select technical contracts and in certain geographies, with some assignments described as substantially above typical consultant rates. Outcomes appear closely aligned to client budgets and market conditions, delivering solid value in higher‑demand niches.
  • Career-Linked Recognition & Rewards Compensation tends to track niche skills and client demand, leading to more favorable pay for specialized technical roles and markets. This structure helps some cohorts perceive their pay as market‑competitive.
  • Wellbeing & Lifestyle Benefits Offerings include access to mental‑health therapy sessions and gym membership or reimbursement. These additions complement core coverage in some roles.

Collabera Insights

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The Company
HQ: Basking Ridge, New Jersey
6,138 Employees
Year Founded: 1996

What We Do

In our relentless pursuit of greatness, we are dedicated to developing individuals, creating exceptional teams, and cultivating a unique culture of unity and care. As providers of digital talent solutions, we aim to positively impact businesses and communities globally. We would be honored to be your trusted and uncommon partner on this journey.

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