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.
Job DescriptionJob Title: Regulatory Affairs Manager
Duration: 06+ months (Possibility to Hire)
Required:
•The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
•In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
•The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
•Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Qualifications• Bachelor's degree required. Scientific or engineering field preferred.
• 5+ years of medical device regulatory affairs experience.
• Must have authored 510(k) submissions
• Must have knowledge of U.S. FDA regulations and standards
• 3+ years of experience interacting with FDA and/or other regulatory agencies
• Experience with devices containing software is strongly preferred.
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
To know more on this position or to schedule an interview, please contact;
Himanshu Prajapat
973-606-3290
himanshu.prajapat[@]collabera.com
Skills Required
- Bachelor's degree in scientific or engineering field
- 5+ years of medical device regulatory affairs experience
- Experience authoring 510(k) submissions
- Knowledge of U.S. FDA regulations
- 3+ years interacting with FDA and/or regulatory agencies
- Experience with devices containing software
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.
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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.
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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.
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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
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.
