Kelly Scientific Resources is currently recruiting candidates for a Regulatory Documentation Specialist position with a medical device company in Jacksonville, FL. The Regulatory Documentation Specialist will be the key documentation expert for the Regulatory Affairs department. This individual will be responsible for coordination, compilation, assembly, and publication of complex regulatory documents, both in paper and electronic formats. They will support project team members with formatting, document standards, and rendering of regulatory documents. Provide final formatting and appropriate rendering of documents for filing and submission including version control and document handling to maintain regulatory compliance. They will maintain accurate records and submission logs; provide clear and timely communication to team members, follow established operating procedures for regulatory document filing and maintenance. Follow established and/or creates new as needed standard operating procedures.
Other Responsibilities / Detailed Duties
- Collaborates with Regulatory Affairs staff to assure adequate prioritization, preparation and dispatch of regulatory submissions, including 501k s, PMAs, INDS and NDAs in paper and eCTD format
- Prepares high quality submissions following regulatory guidelines, internal processes and procedures, style and document standards and utilizing company?s publishing tools, technology and systems
- Performs operational tasks including formatting, editing, publishing, archiving and uploading of documents to document management systems; organize and maintain components of regulatory submissions including template preparation, scanning, printing or filing
- Collect documents to import, edit and/or create in electronic documentation storage and retrieval systems.
- Establish and organize electronic structures for local storage of regulatory submissions, and associated tasks including migration and maintenance of regulatory documents
- Participate in project teams for the publishing of regulatory documents and submissions.
- May prepare training materials and conduct training for users of electronic documentation systems and authors of regulatory documents
- Word processing and document rendering of regulatory documents
- Maintaining document design consistency for all documents to ensure compliance with company document design standards, including the use and maintenance of predetermined templates.
Qualifications / Requirements:
- Assists with the monthly reporting of data for established metrics
- Meets personnel paperwork due dates, e.g., timesheets
- Independently solves routine problems and develops solutions
- Recommends changes to current processes to make them more effective and efficient
- Actively seeks information and knowledge to stay current with regulatory changes and information
- Interacts with employees in a collegial and professional manner
If interested in this position please submit resume through the tool or forward to a friend. We look forward to hearing from you. ?As the local offices of Kelly Services do not represent the above position, please apply on-line for immediate consideration. For questions regarding this position, please phone: 423-884-2241".
- Proficiency in document publishing and management.
- Ability to work independently or under direct supervision.
- Strong organizational skills, accuracy and attention to detail.
- Ability to complete assigned tasks efficiently.
- A team player who is attentive to detail and able to work in a fast paced environment.
- Understanding of FDA guidelines and regulations around technical submission requirements
- Should possess a self starting personality
- Software knowledge: Windows, MS Office ( strong skills required ), Adobe Acrobat Professional, ISI toolbox, Octagon StartingPoint Templates, Submissions publishing tools, XML and SML authoring tools, Labeling Management Systems to support Standard Product Labeling SPL
- Associate or Bachelors degree or 1-3 years experience in regulatory operations or high school diploma or general education degree (GED) with 5 to 10 years related experience and/or training or equivalent combination of education and experience.
- Strong skill level of MS Office required
- Experience with regulatory processes and standards, including publishing software, document standards and Documentum based documentation management systems
- Working knowledge of Agency regulations and industry standards pertaining to regulatory operations
- Good verbal and written communications
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class
staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.
Revenue in 2012 was $5.5 billion.
Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services.
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Kelly Services - 12 months ago
Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...