Regulatory Specialist Resume
Headline : Responsive regulatory professional skilled in cultivating positive client relationships and communicating effectively across an organization, promoting an environment of sustainability and growth.
Skills : Microsoft Office, Document Management, Regulatory Compliance.
Description :
- Managed international projects to improve risk and quality documentation and prepare medical device regulatory compliance dossiers.
- Designed and/or managed multiple data-gathering efforts and analyzed/interpreted data to determine the root cause of problems.
- Provided scientific and technical recommendations for nonconforming engineering test performance results and reports.
- Developed System Failure Modes and Effects Analysis (SFMEA) documentation, root cause analysis of testing variations.
- Implementation of new quality management plans, processes, and regulatory procedures for existing total orthopedic implants in the market.
- Provided technical leadership, product and marketing expertise shaping new product messages with industry leaders.
- Generated a monthly report with product SWOT analysis to Vice Presidents in the company to help identify trends in regulatory decisions.
Experience
5-7 Years
Level
Executive
Education
Masters
Regulatory Specialist/Representative Resume
Summary : Highly reliable and focused Regulatory Specialist with a great depth of experience in compliance related matters. Excellent multitasker able to handle multiple projects efficiently and thoroughly.
Skills : GHS, TSCA, FIFRA, FHSA, VOC and various transport regulations,.
Description :
- Reports, monitors, distributes and maintains files for all safety information including Investigational Drug Brochures, IND safety reports.
- Prepares regulatory documentation packets and creates all FDA 1572 Forms for IND filings.
- Ensures all necessary forms are submitted to the Sponsor Company to activate protocols.
- Distributes and tracks financial disclosure forms, protocol signature pages, and FDA 1572 Forms to obtain local investigator signatures.
- Tracks expirations and retrieves current documentation for medical licensures, CVs and laboratory accreditations.
- Researched ingredient changes in product revisions per state as needed for renewal process.
- Recommended process improvement for cost reduction to the company resulting in a savings of several hundred dollars per month.
Experience
7-10 Years
Level
Management
Education
BS
Regulatory Specialist/Co-ordinator Resume
Summary : Environmental professional with 15 years of proven performance in regulatory compliance and documentation.
Skills : Microsoft Office, ProductVision, Genesis.
Description :
- Actively managed and scheduled work for projects including well staking, filing all State and Federal Permits as they pertained to well drilling and completion.
- Managed a comprehensive stormwater management program for the Piceance Basin in Colorado.
- Worked with operations staff and contractors to manage and implement an annual budget to ensure compliance.
- Worked with multiple agencies including Bureau of Land Management, Colorado Division of Wildlife, and the Colorado Oil and Gas.
- Ensure the uninterrupted development of the ConocoPhillips drilling program and operations.
- Conducted detailed reviews of pending State and Federal legislation and proposed rulemaking, and worked with senior staff.
- Develop and review managements system and policies to ensure they are in compliance with all State and Federal regulations.
Experience
7-10 Years
Level
Management
Education
Biology
Regulatory Specialist III Resume
Summary : Professional, and is currently employed as a Regulatory Specialist. Multi-tasking with the ability to work independently and with a team; highly detail-oriented; good organizational and time management skills.
Skills : Analysing Skills, MS-Office.
Description :
- Communicates with sponsors and other members of the study team regarding sponsors' requests in the initial start-up process.
- Submits and communicates with the Institutional Review Board (IRB) as necessary to obtain approvals of submitted documents.
- Communicates all approvals to the sponsors and their associates including the study team to maintain time points of deliverables.
- Communication with sponsors and associates throughout the participation of the study, as it relates to on-site visits and regulatory documents retrievals.
- Preparation of draft Informed Consent Forms, Initial Submission Application, completion, and submission or Radiation Safety.
- Prepares, facilitates, and coordinates all processes to complete the regulatory aspect of ongoing revisions and timely communication of such.
- Collects and tracks supporting documents for necessary signatures of all persons on the study team at the site level.
Experience
7-10 Years
Level
Management
Education
BS
Regulatory Specialist II Resume
Headline : Clinical Research Consultant with over nine years of health care research experience as a Clinical Monitor, Regulatory Specialist and Clinical Research Coordinator managing projects.
Skills : Microsoft Access, MS-Excel.
Description :
- Managed regulatory and institutional approval for research studies, including initial submissions, modifications, and annual reviews.
- Participated in the design, writing, and review of all project-related documents including proposals, change orders, and study content documents.
- Development of informed consent forms, study documents, and study management tools Monitored TMF for other sites.
- Provided management of investigative sites, including site evaluation and selection, start-up activities and initiation.
- Monitoring and closeout visits and regular communication to collect accurate and complete clinical data, verify source documents.
- Provide drug tracking and disposition as needed as required by the project. Trained coordinators and regulatory staff.
- Lead Clinical Protocol development and training meetings for the research staff.
Experience
5-7 Years
Level
Consultant
Education
MPH
Regulatory Specialist/Executive Resume
Headline : Degreed Chemist with successful career in product development and Quality Assurance. Demonstrated ability to translate FDA and DEA regulations into compliant systems, train personnel.
Skills : ISO 13485:2003 Compliance & Submissions.
Description :
- Responsible for Regulatory Documentation in the Clinical Research Department.
- Ensure all regulations are complied with Problem solve on a daily basis for a variety of issues that arise Communicate to staff on departmental changes.
- Collaborate with physicians, mid-levels and clinical trial team members to effectively and accurately open up clinical trials.
- Track the start-up of all Oncology studies that come to the department, including the Confidentiality agreements.
- Work with the Sanford IRB, as well as over 15 National IRB's. Process all the paperwork once the IRB approves, or requests changes, to the studies.
- Ensure Informed Consent documents are continuously available, accurate, and IRB approved at all times.
- Work with Sanford's legal department to ensure the contract and the informed consent documents are each saying the same thing.
Experience
5-7 Years
Level
Executive
Education
Human Services
Regulatory Specialist I Resume
Objective : Eighteen years of experience in licensing and permitting, land use regulations, environmental compliance, consulting, and natural resource management for projects.
Skills : Phlebotomy, ECG.
Description :
- Maintains and provides information and documents, and responds to questions from individuals or groups concerning licenses.
- Performs detailed research to answer inquiries from those who are currently licensed or seeking licensure.
- Understands and interprets statutes, Department and/or Board rules and regulations.
- Exercises independent judgment in dealing with consumers and licensees. Navigates computer systems to obtain information.
- Complete study start-up Maintained regulatory documents Assisted in developing study budgets.
- Assist coordinators in preparation for internal and external audits Assisting CRA during monitoring visits Track study-specific regulatory documents.
- Maintained existing standards and identified new applicable standards Audit preparation for FDA, BSI and internal audits.
Experience
2-5 Years
Level
Junior
Education
Management
Lead Regulatory Specialist Resume
Headline : Looking for a job with a fast paced company with many chances to advance. Ability Summary Ability to listen effectively and redirect customers and clients to ensure positive outcomes.
Skills : Strong computer skills and exposure to Microsoft Word, Data Entry.
Description :
- Greeted and assisted potential practitioners beginning the process to apply for a professional medical license.
- Maintained a working knowledge of both PRAES and COMPAS data base.
- Provided detailed research to answer inquires from persons seeking profiling and licensure data information for licenses within Florida.
- Maintained working knowledge of department and board rules practiced and exercised independent judgment in dealing with practitioners.
- Provided information and technical support to practitioners seeking access to the on line data base to renew license.
- Informed practitioners of deficiencies of renewal information, Assisted persons seeking profiling or unlicensed activity data.
- Researched the concerns or problems of practitioner profiles and exercised considerable independent judgment.
Experience
5-7 Years
Level
Executive
Education
Psychology
Sr. Regulatory Specialist Resume
Headline : Highly motivated, goal-driven, and results-oriented professional with exemplary planning, prioritizing, and goal-setting skills, eager to obtain a position in business arena.
Skills : MS-Office, MS-Excel.
Description :
- Directly responsible for evaluating compound financial data, preparing financial reports to determine financial performance.
- Prepare and organize descriptive, management, and statistical financial reports for government officials.
- Collaborate with personnel encompassing field offices for bi-weekly timesheets and ensure timely data processing into the CEFMS system.
- Develop reports on departmental human resource and training functions.
- Ensuring adherence to regulations, local guidance, due dates and deadlines associated with the government credit card program.
- Correspond with other government agencies and commercial vendors to resolve billing/payment issues relating to goods and services.
- Prepare a wide variety of civilian personnel forms and reports for Section/Branch personnel.
Experience
5-7 Years
Level
Executive
Education
MBA
Jr. Regulatory Specialist Resume
Objective : To obtain position in a dynamic environment that will allow for further development of interpersonal and administrative skills.
Skills : Quality Assurance, Technical Writing, Auditing.
Description :
- Provide Regulatory support during FDA and other regulatory agency audits Internal auditing - Audit each department to ensure Quality Compliance.
- Ensure the timely implementation of internal audit action plan implementations as well as effectiveness checks.
- Complaint Handling - Investigations through root cause analysis, RMAs, and CAPA investigation.
- Administration of daily activities that support registrations, submissions, and reporting activities, including data analysis and customer care meeting.
- Ensure the timely completion of CAPA action plans by their owners, as well as perform effectivity checks to verify proper implementation of the action plan.
- Prepare and modify documentation for Technical Files, Design History Files, and Device Master Records.
- Maintain and update standards library standards in accordance with current requirements.
Experience
2-5 Years
Level
Junior
Education
Health Sciences
Associate Regulatory Specialist Resume
Summary : Determined and engaging NYU Graduate with a Masters Degree in Archives and Public History, RAC Certification and six years of work experience in Regulatory Affairs & Quality Assurance for the medical device industry.
Skills : Regulatory Compliance, Teaching, Data Entry, Hiring, Data Entry.
Description :
- Examined and processed unemployment insurance initial, renewed, and claims pertaining to intrastate, interstate, federal employees.
- Reviewed and processed initial and contested wage record documents from local offices and employers for use in establishing monetary eligibility.
- Reviewed written protests from employers and prepares the same for processing.
- Updated computer records to correct errors reflected by computer-generated error lists, appeal decisions, court cases, and requests by local offices.
- Initiated action to generate benefit payments resulting from the deletion and/or correction of computer records.
- Reviewed cases to assess fraud and/or over-payment, arranged repayment schedules for claimants.
- Adjudicated claims and rendered non-monetary determinations based on an examination of records and information.
Experience
7-10 Years
Level
Management
Education
Sociology
Regulatory Specialist Resume
Headline : To acquire a position that requires outstanding customer service, analytical, and communication skills. A position with a growing organization where one can use their talents to help others achieve their goals.
Skills : MS-Office, MS-Excel.
Description :
- Evaluates and advises the organization on methods and procedures for providing administrative support systems.
- Manages regulatory systems in a database including label information, packaging codes, bill of materials, formulas.
- Analyzes management information requirements to develop administrative reporting systems including the system's specifications.
- Advises on the potential benefits of automation to improve the efficiency of program operations.
- Researches and investigates improved business and management practices for application to the company's operations.
- Serves as the direct problem solver on daily issues that affect the overall performance of Fuchs North America, Inc.
- Interprets existing or new regulatory requirements as they relate to company products and procedures.
Experience
5-7 Years
Level
Consultant
Education
MBA