- *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirementsIdentifies, analyzes and implements country specific requirements necessary for product related submissions.
- *Recommend strategies for earliest possible approvals for marketing applicationsPerforms regulatory projects or acts as a member of the project steering group.
- Submits required documentation/information to local authorities or Client/Varian internal.
- Initiates and escalates necessary activities if deviations are identified.
- Ensures creation of adequate documentation for audits/inspections.
- Performs training within the organization in country specific regulatory requirements, if applicable.
- *Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.Performs review of promotional material for regulatory compliance according to country specific requirements.
- Product Registration Experience:
- Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files
- Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
- Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
- Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO as evidenced by coursework or submissions that required use of each standard
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Regulatory Affairs Specialist - Palo Alto, United States - Net2Source Inc.
Description
Job Title: Regulatory Affairs Professional 4
Duration: 12 months (Possible Extension)
Pay Rate: $68.89/hr.
Location: Palo Alto CA USA 94304 Hybrid
Need Local Candidates to Palo Alto CA
Job role required to support tasks for software and VBT projects.
Position Description:
Key Responsibilities: "Senior Professional " Positions which need senior professional expertise, with extensive functional, commercial and/or technical knowledge in an area of competence. They integrate analysis, development, testing and implementation. They interpret and functionally influence policy and guidelines in their area of business / technology, and develop processes and systems to deliver functional objectives. They typically plan own work according to targets agreed, within a quarterly up to an annual cycle, by integrating resources in a project driven environment. They provide functional advice and guidance to colleagues and customers. A chartered professional qualification or equivalent is typically associated with grades (though not necessary).
Experience: 5-8 years.
Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches
Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
