Regulatory Affairs Manager

Summary of Responsibilities

Regulatory Affairs/In Vitro Diagnostics Manager will be responsible for managing Design Control process, device validations and verifications, clinical trials, 510(k) and other regulatory submissions. In addition, the Regulatory Manager will be responsible for license renewals, periodic regulatory updates, assisting international distributors with product registrations, and compliance with national and international regulatory guidelines.

Essential Duties and Responsibilities

  • Understand FDA, EU, Latin American and other countries’ regulations in medical device/IVD, pre/post marketing registrations, Quality System, GMP compliances, UL and other international standards.
  • Plan strategies for FDA and foreign market device entry and clearance.
  • Collect and coordinate information and prepare regulatory documentation, such as 510(k)s, for submission to regulatory agencies or commercial partners.
  • Oversee product validation and verification activities.
  • Assemble and maintain regulatory files/DHF in good order.
  • Coordinate clinical trials and other studies with collaborating institutions and prepare associated documentation.
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions.
  • Provide the regulatory reviews of customer complaints and define the regulatory reportability.
  • Maintain current 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.
  • Devise and communicate regulatory responses (written and verbal) to peers, customers, and regulatory bodies.
  • Attend conferences when applicable.
  • Manage a small staff of development and clinical trial employees

Qualifications

To meet standards of this position, personnel must be able to perform each essential duty with proficiency.

  • Knowledge or experience in establishing and implementing regulatory strategies, including 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.
  • Previous managerial experience preferred.

Education and Experience

  • B.S in a science or related field.
  • Minimum ten years of in vitro diagnostic experience with a medical device company.
  • At least 10 years relevant experience within the regulatory affairs discipline including experience with Class II devices.
  • Strong interpersonal and leadership skills.
  • Proven track record of successful regulatory submissions to the FDA and international agencies.

Apply today for the Regulatory Affairs Manager position at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to careers@miravistalabs.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.

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