Regulatory Affairs Manager​/Regulatory Affairs Specialist

Regulatory Affairs Manager / Regulatory Affairs Specialist role

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 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.
• 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;