Ivdr Regulatory Affairs Specialist Ii

Amazing opportunity for an experienced IVDR Regulatory Affairs professional to join a nationwide organization. This is a remote position for someone with strong IVDR (In Vitro Diagnostic Regulation) experience, submission work, IDE or 510k, etc.

Summary of responsibilities for this Regulatory Affairs Specialist II

• Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
• Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues or questions in the applications.
• Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of products domestically (United States) and internationally (EU/Canada/ROW).
• Develop plans to receive approvals to sell products identified in the marketing sales plan.
• Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
• Participate on project teams as regulatory or as RA/QA/CA representative.
• Mainly responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company.
• Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.
• Timely preparation of regulatory submissions to the FDA, international dossiers/technical files required for CE Mark for EU countries and other international product registration files as required for ROW distribution.

Desired Qualifications

• Three-four years regulatory submissions work in domestic/international registrations and IVDR experience required.
• Must have done some submission work… IDE or 510K (Premarket Notification).
• Regulatory Accreditation Certificate is a plus.
• Experience with IVD PMA submissions preferred.
• Design control background is great but is not required. (Preferred).
• Bachelor’s degree (Master’s degree is a plus) with a minimum of 5 years of experience in a regulated industry.

Apply Now! Qualified candidates will be reached within 24-48 hours.