Regulatory Affairs Professional 4

Job Title: Regulatory Affairs Professional 4

Duration: 3 Months Possible Extension

Location: 9825 Spectrum Drive, Austin, TX, USA 78717

Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements * Identifies, analyzes and implements country specific requirements necessary for product related submissions. *Recommend strategies for earliest possible approvals for marketing applications * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentation/information to local authorities or Siemens/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.

Impacts: Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.

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.

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 10993-1 as evidenced by coursework or submissions that required use of each standard

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