Cogentix Medical Senior Regulatory Affairs Specialist in Minnetonka, Minnesota
Cogentix Medical offers exciting opportunities for individuals who want to make a difference in the lives of patients throughout the world. If you are looking for an innovative company that appreciates your contributions and individualitywhile fostering teamwork, then Cogentix Medical may be the place for you.
Perform regulatory affairs functions to ensure compliance with applicable laws and regulations in the development, manufacturing, and marketing of allCogentix Medicalproducts. The Regulatory Affairs Specialist will be knowledgeable of U.S. FDA regulations, the European Medical Device Directives, and the Canadian Medical Device Regulations. The Regulatory Affairs Specialist will use this knowledge to support pre-market and post-market activities and will work closely with Quality Assurance, Clinical Affairs, Sales and Marketing, Engineering, and Manufacturing.
Assist with the preparation of 510(k) and Pre-Market Approval (PMA) submissions
Manage applicable post-market regulatory activities such as establishment registration updates and FDA annual reports
MaintainCogentix technical files in compliance with the European Medical Device Directives.
Prepare technical documentation such as literature reviews or research reports describing the safety and efficacy ofCogentix products.
Assist Cogentix Medicaldistributors with updating and renewingCogentixMedical product registrations as required.
Assist with the preparation of Investigational Device Exemptions (IDE’s) as assigned.
Assist clinical staff with the preparation of IDE annual reports, site waiver reports, or other required clinical documentation or reports.
Prepare and submit documentation in compliance with the Canadian Medical Device Regulations.
Review company marketing literature for compliance to applicable regulations
Provide regulatory guidance to other Cogentix Medical departments upon request.
Perform regulatory, quality, and clinical compliance audits upon request.
Bachelor'sdegree majoring in a science or public health related field.
Working knowledge of the key medical device requirements of US CFR Title 21, European MDD 93/42/EEC and associated harmonized standards, and the Canadian Medical Device Regulations
PC proficient in Windows environments. Working knowledge of word processing, spreadsheets, e-mail and web-enabled applications
Effective writing and communication abilities.
Strong ability to multitask and work in multi-disciplined teams
Flexible Spending Account (FSA)
Basic Life Insurance
Voluntary Life Insurance
Short Term & Long Term Disability
Paid Sick Leave
Identity Theft Protection