Regulatory Affairs Associate I, II, or III
Regulatory Affairs/In Vitro Diagnostics Associate will be assisting with all aspects of regulatory functions, including: regulatory assessments, maintenance of regulatory files, compliance with design control procedures, adherence to national and international regulations. In addition this individual will assist with 510(k) and international regulatory submissions and communications with regulatory agencies, prepare clinical trial protocols and IRB submissions, as needed.
Essential Duties and Responsibilities
To meet standards of this position, personnel must be able to perform each essential duty with proficiency.
- Exposure to and understanding of FDA and international regulations in medical device/IVD, pre/post marketing registrations, Quality System, GMP compliances, UL and other international standards.
- Assist in collecting and coordinating information and preparation of regulatory documentation, such as 510(k)s, for submission to regulatory agencies or commercial partners.
- Assist in assembly and maintenance of regulatory files/DHF in good order.
- Assist with the regulatory reviews of customer complaints and define the regulatory reportability.
- Knowledge of FDA and international regulations, guidance and standards applicable to company products.
- Participate in research of regulatory issues and disseminate regulatory information to Production, QA, and R&D as required.
- Assist with communication of regulatory responses (written and verbal) to peers, customers, and regulatory bodies.
- Knowledge and experience assisting in FDA submissions.
- Excellent oral and written communication and interpersonal relations skills.
- Experience in project management tools and applications such as MS word, Excel, PowerPoint, Project management software.
- The ability to work well under pressure, manage multiple tasks and adapt to changing priorities
Education and Experience
- B.S in a science or related field.
- Minimum 2-5 years of in vitro diagnostic experience with a medical device company
- At least 2-5 years relevant experience within the regulatory affairs discipline including experience with Class II devices.
- Strong interpersonal and leadership skills.
Apply today for the Regulatory Affairs Associate I, II, or III positions at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to email@example.com if you have any problems with the web form).
MiraVista Diagnostics was established in 2002 and operates a fast-paced onsite clinical laboratory in Indianapolis where we process more than 100,000 diagnostic tests for serious fungal infections each year.