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Sr. Regulatory Operations Specialist

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Job Type
Direct Hire
Dec 05, 2018
Job ID
Our mid-sized medical device client has a small office in the southwest suburbs and they are looking to add a Sr. Regulatory Operations Specialist to their team! This person will have the opportunity to work remote 2 days a week.  They have doubled revenue in 36 months. This will be a great opportunity to learn new things and gain new experiences in a smaller, more nimble company 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 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 the company.  This position will help maximize the amount of patients served while maintaining a high level of quality and safety through the support of the business functions.     

Your role with the company:

• 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 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 company
• 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 sites.
• Prepare and/or assist in various ad hoc projects (e.g. educational materials, senior management presentations, white papers etc.)

Desired Profile:
• 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.