Regulatory Affairs Specialist jobs in Fremont, CA

Responsibilities:

• Participate on project teams as regulatory or as RA/QA/CA representative.
• 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.
• 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.
• Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues in the applications.
• Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
• Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.

Requirements:

• with a minimum of 3 years' experience in a regulated industry. Three-four years regulatory submissions work in domestic/international registrations and IVDR experience required.
• Experience with IVDR/ IVD PMA submissions preferred.
• Ability to read and analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to messages from employees, managers, vendors, or customers. Ability to effectively communicate plans, issues and resolve problems/conflicts in a project team setting.