Job ID: 784Location: St. Louis, MODepartment: Regulatory Affairs – Post MarketEducation Required: Bachelors DegreeExperience Required: 3 – 5 YearsPosition Description: Scientific and technological innovation is at the heart of the bioM©rieux strategy.
bioM©rieux specializes in the in vitro diagnostics sector; we design, develop, produce, and market diagnosis systems for the medical and industrial application.
More than 40 years of experience in the field of infectious diseases allows bioM©rieux, a world leader in microbiology, to respond to major public health issues, and affirm its position as a key player in clinical diagnostics and industrial microbiologically quality control.
With a presence in over 150 countries, the world headquarters is located in Marcy-l’Etoile, France.
North American locations include Durham, NC, Portland OR, Lombard, IL, and St. Louis, MO. We offer a team based environment with exceptional benefits which includes an employee friendly corporate culture, generous paid time off, pension plan, 401(k) with company match, tuition assistance, comprehensive health plan and career development opportunities.
The Sr. RA Export Compliance Specialist Is responsible for the evaluation, coordination, preparation and implementation of all Regulatory Affairs Export Compliance activities.
Ensures timely preparation of organized and scientifically valid reports both internally and externally.
Interacts directly with regulatory agencies on export compliance product issues and questions.
Under the guidance of the direct supervisor, provides advice to and represents RA on specific project teams.
Creates, monitors and controls Regulatory project schedules related to export compliance activities.
Monitors change in the regulatory environment, evaluate impact and communicate to interested parties.The Sr. Specialist is expected to function at a level that does not require significant daily supervision by the direct supervisor.
The Sr. Specialist is required to apply critical thinking and problem solving to complex export regulatory issues on a daily basis, and must be able to efficiently and effectively multi-task on all responsibilities.
1. Must obtain and maintain a working knowledge of the Export Compliance Program and export laws and regulations applicable to bioMerieux.
Monitor regulatory and internal changes to ensure up-to-date compliance by drafting, implementing and enforcing export compliance procedures applicable to bioMerieux, Inc on a global level2 Develop and maintain a jurisdictional classification matrix that includes export classifications for all bioMerieux products (broken out by model and product family).
Ensure that the classifications are properly and consistently applied in the global ERP system.
Confirm that bioMerieux products are not implicated by advanced export regulations relating to military and space applications3 In accordance with the general prohibitions under the US export laws that prohibit products from use by certain end-users and for certain end-uses, coordinate with the global marketing, commercial operations, research and development and shipping departments within bioMerieux to maintain proper monitoring of such end-users and end-uses of bioMerieux products.
4. Prepare and execute a training program that would reach each internal stakeholder (including Management) in the process, which should include third party distributors and intermediaries involved in the commercialization of bioMerieux products as well.
5. Develop and implement an audit process that includes specifics as to when and where audits are to be performed, what functions of the process will be reviewed, and who will support the Export Compliance Administrator in performing the audits.
Position Requirements: Required
1. Bachelors degree in a scientific discipline.
2. Minimum of three years experience in Regulatory Export Compliance.
Ideal if experience is specific to Medical Devices, In Vitro Diagnostics Devices, or Biologics.
3. Excellent verbal and written communication skills.
4. Good negotiation and diplomatic skills.
5. Leadership Skills.
6. Must have good PC skills and be proficient Office Windows environment, particularly Word and Excel.
7. Must be highly analytical and able to evaluate, analyze, and summarize large volumes of data and technical material efficiently.
8. Excellent organizational and presentation skills.
9. SAP proficiency ideal, but not required.
Equal Opportunity/Affirmative action employer M/F/D/V.
Sr. Regulatory Affairs Export Compliance Specialis Job in Saint Louis 63101, Missouri US