Regulatory Specialist Resume Samples

Description :

1. Managed international projects to improve risk and quality documentation and prepare medical device regulatory compliance dossiers.
2. Designed and/or managed multiple data-gathering efforts and analyzed/interpreted data to determine the root cause of problems.
3. Provided scientific and technical recommendations for nonconforming engineering test performance results and reports.
4. Developed System Failure Modes and Effects Analysis (SFMEA) documentation, root cause analysis of testing variations.
5. Implementation of new quality management plans, processes, and regulatory procedures for existing total orthopedic implants in the market.
   
6. Provided technical leadership, product and marketing expertise shaping new product messages with industry leaders.
7. 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

Description :

1. Reports, monitors, distributes and maintains files for all safety information including Investigational Drug Brochures, IND safety reports.
2. Prepares regulatory documentation packets and creates all FDA 1572 Forms for IND filings.
3. Ensures all necessary forms are submitted to the Sponsor Company to activate protocols.
4. Distributes and tracks financial disclosure forms, protocol signature pages, and FDA 1572 Forms to obtain local investigator signatures.
5. Tracks expirations and retrieves current documentation for medical licensures, CVs and laboratory accreditations.
6. Researched ingredient changes in product revisions per state as needed for renewal process.
7. 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

Description :

1. Actively managed and scheduled work for projects including well staking, filing all State and Federal Permits as they pertained to well drilling and completion.
2. Managed a comprehensive stormwater management program for the Piceance Basin in Colorado.
3. Worked with operations staff and contractors to manage and implement an annual budget to ensure compliance.
4. Worked with multiple agencies including Bureau of Land Management, Colorado Division of Wildlife, and the Colorado Oil and Gas.
5. Ensure the uninterrupted development of the ConocoPhillips drilling program and operations.
6. Conducted detailed reviews of pending State and Federal legislation and proposed rulemaking, and worked with senior staff.
7. 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

Description :

1. Communicates with sponsors and other members of the study team regarding sponsors' requests in the initial start-up process.
2. Submits and communicates with the Institutional Review Board (IRB) as necessary to obtain approvals of submitted documents.
3. Communicates all approvals to the sponsors and their associates including the study team to maintain time points of deliverables.
4. Communication with sponsors and associates throughout the participation of the study, as it relates to on-site visits and regulatory documents retrievals.
5. Preparation of draft Informed Consent Forms, Initial Submission Application, completion, and submission or Radiation Safety.
6. Prepares, facilitates, and coordinates all processes to complete the regulatory aspect of ongoing revisions and timely communication of such.
7. 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

Description :

1. Managed regulatory and institutional approval for research studies, including initial submissions, modifications, and annual reviews.
2. Participated in the design, writing, and review of all project-related documents including proposals, change orders, and study content documents.
3. Development of informed consent forms, study documents, and study management tools Monitored TMF for other sites.
4. Provided management of investigative sites, including site evaluation and selection, start-up activities and initiation.
5. Monitoring and closeout visits and regular communication to collect accurate and complete clinical data, verify source documents.
   
6. Provide drug tracking and disposition as needed as required by the project. Trained coordinators and regulatory staff.
7. Lead Clinical Protocol development and training meetings for the research staff.

Experience

5-7 Years

Level

Consultant

Education

MPH

Description :

1. Responsible for Regulatory Documentation in the Clinical Research Department.
2. 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.
3. Collaborate with physicians, mid-levels and clinical trial team members to effectively and accurately open up clinical trials.
4. Track the start-up of all Oncology studies that come to the department, including the Confidentiality agreements.
5. 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.
6. Ensure Informed Consent documents are continuously available, accurate, and IRB approved at all times.
7. 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

Description :

1. Maintains and provides information and documents, and responds to questions from individuals or groups concerning licenses.
2. Performs detailed research to answer inquiries from those who are currently licensed or seeking licensure.
3. Understands and interprets statutes, Department and/or Board rules and regulations.
4. Exercises independent judgment in dealing with consumers and licensees. Navigates computer systems to obtain information.
5. Complete study start-up Maintained regulatory documents Assisted in developing study budgets.
6. Assist coordinators in preparation for internal and external audits Assisting CRA during monitoring visits Track study-specific regulatory documents.
7. Maintained existing standards and identified new applicable standards Audit preparation for FDA, BSI and internal audits.

Experience

2-5 Years

Level

Junior

Education

Management

Description :

1. Greeted and assisted potential practitioners beginning the process to apply for a professional medical license.
2. Maintained a working knowledge of both PRAES and COMPAS data base.
3. Provided detailed research to answer inquires from persons seeking profiling and licensure data information for licenses within Florida.
4. Maintained working knowledge of department and board rules practiced and exercised independent judgment in dealing with practitioners.
5. Provided information and technical support to practitioners seeking access to the on line data base to renew license.
6. Informed practitioners of deficiencies of renewal information, Assisted persons seeking profiling or unlicensed activity data.
7. Researched the concerns or problems of practitioner profiles and exercised considerable independent judgment.

Experience

5-7 Years

Level

Executive

Education

Psychology

Description :

1. Directly responsible for evaluating compound financial data, preparing financial reports to determine financial performance.
2. Prepare and organize descriptive, management, and statistical financial reports for government officials.
3. Collaborate with personnel encompassing field offices for bi-weekly timesheets and ensure timely data processing into the CEFMS system.
4. Develop reports on departmental human resource and training functions.
5. Ensuring adherence to regulations, local guidance, due dates and deadlines associated with the government credit card program.
6. Correspond with other government agencies and commercial vendors to resolve billing/payment issues relating to goods and services.
7. Prepare a wide variety of civilian personnel forms and reports for Section/Branch personnel. 

Experience

5-7 Years

Level

Executive

Education

MBA

Description :

1. Provide Regulatory support during FDA and other regulatory agency audits Internal auditing - Audit each department to ensure Quality Compliance.
2. Ensure the timely implementation of internal audit action plan implementations as well as effectiveness checks.
3. Complaint Handling - Investigations through root cause analysis, RMAs, and CAPA investigation.
4. Administration of daily activities that support registrations, submissions, and reporting activities, including data analysis and customer care meeting.
5. 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.
6. Prepare and modify documentation for Technical Files, Design History Files, and Device Master Records.
7. Maintain and update standards library standards in accordance with current requirements.

Experience

2-5 Years

Level

Junior

Education

Health Sciences

Description :

1. Examined and processed unemployment insurance initial, renewed, and claims pertaining to intrastate, interstate, federal employees.
2. Reviewed and processed initial and contested wage record documents from local offices and employers for use in establishing monetary eligibility.
3. Reviewed written protests from employers and prepares the same for processing.
4. Updated computer records to correct errors reflected by computer-generated error lists, appeal decisions, court cases, and requests by local offices.
5. Initiated action to generate benefit payments resulting from the deletion and/or correction of computer records.
6. Reviewed cases to assess fraud and/or over-payment, arranged repayment schedules for claimants.
7. Adjudicated claims and rendered non-monetary determinations based on an examination of records and information.

Experience

7-10 Years

Level

Management

Education

Sociology

Description :

1. Evaluates and advises the organization on methods and procedures for providing administrative support systems.
2. Manages regulatory systems in a database including label information, packaging codes, bill of materials, formulas.
3. Analyzes management information requirements to develop administrative reporting systems including the system's specifications.
4. Advises on the potential benefits of automation to improve the efficiency of program operations.
5. Researches and investigates improved business and management practices for application to the company's operations.
6. Serves as the direct problem solver on daily issues that affect the overall performance of Fuchs North America, Inc.
7. Interprets existing or new regulatory requirements as they relate to company products and procedures.

Experience

5-7 Years

Level

Consultant

Education

MBA