What are the responsibilities and job description for the Regulatory Affairs Manager / Regulatory Affairs Specialist role position at Collabera?
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.
Job Description
Job 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
Additional Information
To know more on this position or to schedule an interview, please contact;
Himanshu Prajapat
973-606-3290
himanshu.prajapat[@]collabera.com
