Sr. Specialist, Regulatory Operations

Position Summary:
This position will be responsible for analyzing and supporting/resolving functional business issues and needs, as well as meeting assigned performance objectives, completing assigned tasks, and achieving set metrics in area of specialization. The Sr. Specialist will is often the leader of their specialized function and will help develop as well as ensure adherence to company policy and procedures, and will assist in maintaining these systems throughout RTI Surgical. This position will help RTI Surgical maximize the amount of patients served while maintaining a high level of quality and safety through the support of the business functions.
Responsible for supporting assigned department or function while acting as a liaison to internal and external customers
Participates and assists in internal and external requests. Assists in immediate action and correction of operational issues and complaints
Responsible for ensuring assigned metrics are maintained; which may also include preparing, tracking, and trending reports, conducting audits and providing timely feedback to stakeholders
Develop and maintain effective working relationships with RTI management team and staff to support needs of the business and ensure requested information is obtained timely, is complete and accurate
Support company and departmental quality and business objectives and initiatives
Drive/participate in the development and continuous improvement of the systems and procedures to ensure effective/ efficient operations
Assures timely document reviews and proper and timely document productions. Provide effective communication and support to internal and external staff, management and customers
Focus on initiative, driving innovation, and customer service
Develop strategies and implement documentation standards, procedures, and timelines related to the formatting, publishing, and archiving of regulatory submissions to drive consistent approaches across RTI
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions and electronic regulatory technical documents in compliance with document management standards.
Develop strategies and implement activities related to enterprise-wide regulatory management systems, including training, regulatory metrics, new and changing regulations.
Understand regulatory needs to provide inputs to other enterprise wide systems and databases for appropriate controls and validations.
Assist manager, Regulatory Operations in continuous process and system improvements for harmonized approach for all RTI sites.
Prepare and/or assist in various ad hoc projects (e.g. educational materials, senior management presentations, white papers etc.)
Other duties as assigned
Education/Experience Required:
At least 3 years of experience in regulatory operations area
Bachelor's Degree required
Ability to anticipate and meet deadlines, and the ability to retain confidential information.
Excellent organizational skills and demonstrated ability to handle multiple tasks accurately and efficiently
Experience on working in fast-paced environment, ability to work under pressure.
Excellent communication and presentations skills
Experience on working in a cross-cultural environment and participating in global systems
Advanced knowledge of word processing, spreadsheet/graphing, database and graphics presentation applications, including knowledge of Microsoft Office applications.
Working knowledge of enterprise systems like SAP, Agile, etc.

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