REGULATORY AFFAIRS SPECIALIST ** Medical Diagnostic Devices
Chek Diagnostics, a medical diagnostic device manufacturing, is hiring a Regulatory Affairs Specialist in Indianapolis, IN.
- Are you a medical device compliance expert with project management and leadership skills?
- Do you have a passion for quality?
- And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth?
At Chek Diagnostics, we take great pride in delivering industry-leading point-of-care and home diagnostics to the global health care market. Our focus is the development of diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions.
With 30% annual growth and strong profitability, we have committed to the ongoing development of innovative products for the early diagnosis and the ongoing management of these diseases; we take the business of supplying the highest quality, most technologically advanced tools possible very seriously. Founded in 1992, Chek Diagnostics is headquartered in Indianapolis, Indiana, USA. Our products are represented in more than 100 countries worldwide.
As our Regulatory Affairs Specialist, you will coordinate and facilitate U.S. regulatory submissions and international registrations for new products. Provide advice and strategic planning with regards to compliance issues related to the FDA and EOUS regulatory requirements pursuant to FDA Code of Federal Regulations and EU in Vitro Device Directive, ISO and CE Mark requirements. Reporting to the Regulatory Affairs Manager, you will work with a cross functional team (R & D, Head of Quality, Sales and Marketing, and Product Support) while taking ownership of all submission processes.
- Write and submit US regulatory submissions including, pre-IDEs, IDEs, 510(k)’s, and correspond with FDA regarding submissions, as required.
- Write and submit OUS regulatory submissions, including product registrations and licensing.
- Work with project teams as the Regulatory Affairs representative, coordinating the collection of technical data to support submissions.
- Provide direction and guidance in the interpretation of US FDA and other International regulations and standards.
- Minimum 2 years of experience working in a regulatory submissions or compliance capacity in a regulated medical industry, preferably the Medical Devices industry
- A Bachelors degree in Biology, Chemistry, Medical Technology or related field required.
- Experience with U.S. FDA submission, International registration and marketing approval processes.
- Knowledge of Good Manufacturing Practices (GMPs) and applicable EU directives and ISO standards for IVD and Point of Care (POC) devices.
- IVD/POC laboratory experience and/or training preferred.
- Ability to interact with numerous internal and external customers as the “face of the business” including regulatory agencies.
- Must have a high level of multi-task management and be able to use program management tools such as MS Excel and MS Project.
- Detailed oriented and ability to document effectively and completely.
- Excellent communication skills, both written and verbal.
COMPENSATION AND BENEFITS:
Chek Diagnostics will reward your talents with a total compensation package commensurate with experience. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, LT disability, PTO, and 401(k) retirement plan with company match.
If you are a medical device compliance expert, we encourage you to apply online now. We prefer that you submit an electronic resume via this career site.
To learn more about Chek Diagnostics, please visit www.cardiochek.com.
Chek Diagnostics requests that all candidate or recruiter inquiries be directed to Safari Solutions.
Drew Smith, HR Consultant
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