Regulatory Analyst
HCL offers you a career in Engineering and R&D. With us, you get to use your engineering and analytical skills to provide innovative solutions to our global customers.
You will learn and work on new-age technologies as we enable our customers across industries in their digital transformation. At HCL, creativity, and innovation take wings as we engineer next-gen customer experiences.
Role and Responsibilities
- Identification of applicable regulatory standards and requirements for said Medical devices
- Classification of Medical Devices based on USFDA, EU and other National/Regional regulations
- Identification of ‘Substantially Equivalent’ devices with proper justification
- Interpretation of regulations/standards’ requirement statements and assist Project team to derive design requirement statements or compliance assessment
- Identification of applicable labeling requirements
- Identification of applicable safety and compliance tests
- Support for the preparation and compilation of Technical Files for regulatory submission
· Support Project teams for DHF and DMR preparations
Qualifications
- Bachelors Degree in Computer Science, Information Technology, or a STEM Field
- Cumulative 3.0 + GPA
- Location: Cincinnati, OH
- US Work Authorization Required
HCL Recognitions
- Forbes magazine World’s BEST employers
- NCWORKS Governor’s Award for “Outstanding Employer of the State” in North Carolina
- Recognized by Gartner As a Leader for Managed Workplace Services, “Leader” in North America
- Gartner Magic Quadrant For Data Center Outsourcing & Infra Utility Services, North America
- We’re celebrating becoming a Great Place to Work-Certified™ company! #GPTWcertified - Check out what my co-workers say makes working at HCL Technologies (@hcltech) so great:
About HCL
We are a leading global technology company offering services and products through three business units - IT and Business Services, Engineering and R&D Services, and Products & Platforms. We use the latest technologies – AI, IoT, Machine Learning, and Cloud – to identify and solve the most complex business problems across a wide number of industries. Our foundation is built on four decades of innovation, a world-renowned, employee-centric culture, a strong base of invention and risk-taking, and a relentless focus on customer relationships.
With a worldwide employee base of 170,000+ ” Ideapreneurs” working in 46 countries and a network of global R&D, innovation labs, and delivery centers, HCL serves leading enterprises, including 250 of the Fortune 500 and 650 of the Global 2000.
Our Presence in the Americas
It’s been three decades since HCL started its business in Americas. It has now grown to build a flourishing business which now boasts of 20,000 strong workforce across 15-offices and 6-global delivery centers. Better still, we’ve had the opportunity to contribute to the growth and technological excellence of hundreds of blue-chip American companies and also to positively impact the IP portfolio, R&D legacy, IT landscape, and talent pool of Americas through close collaboration with government, universities and local communities. Our success has been led by the immense talent of highly motivated individuals who are drawn to solving challenges in an entrepreneurial environment. We are proud to have also received multiple accolades, such as receiving the “Outstanding Employer in the State” honor in North Carolina. We are looking for like-minded people to join us in our next phase of our transformation journey and welcome you to grow with us.
Our Culture
At HCL, we don’t just accept the differences—we support it and celebrate it. We are committed to cultivating and preserving a culture of inclusion and connectedness. We are able to grow and learn better together with a diverse team of employees. As an equal opportunity employer, we stay true to our mission by ensuring that our place can be anyone’s place.