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Regulatory Affairs Professional

Company: Siemens
Location: Knoxville
Posted on: September 12, 2019

Job Description:

Regulatory Affairs Professional + Knoxville, Tennessee + Quality Management + ****** Siemens Healthineers Share Job **Job Description** **Organization:** Siemens Healthineers **Business Unit:** Diagnostic Imaging **Requisition Number:** ****** **Primary Location:** United States-Tennessee-Knoxville **Assignment Category:** Full-time regular **Experience Level:** Mid level **Education Required Level:** Bachelor's Degree **Travel Required:** 15% **Job Description:** **Nows our time to inspire the future of healthcaretogether.** Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. Join our team now at Siemens Healthineers as _aRegulatory Technical Specialist 2_ **This is a role well suitedto an ambitious professional, looking for the next step in their career. Asa** **RegulatoryTechnical Specialist 2,** **you will be responsible for** : + You will be responsible for supporting thecompilation,submission and maintenance of 510(k) pre-market notifications andinternational regulatory filings. + You will coordinate worldwide product licensingactivities including the gathering of data and the submission ofregistration documents to in-country Siemens Regulatory Representatives + You will support the review of promotionalmaterialto ensure theyare compliant with the productregulatory clearances/approvals + You will stay current on global regulatory requirementsand will be engaged in the implementation of new regulations **This position may suit youbest if you are familiar with** **what is below,** **and wouldlike to do develop your career with Healthineers** + You have demonstrated a working knowledge of FDA 510(k)pre-market notification requirements through successful submissions + You haveabasicunderstandingof EU medical device requirements (MDD and MDR) + You have a general understanding of QualitySystem Requirements (FDA QSR and ISO 13485) + You have a working knowledge of the medical deviceregulations in China, Canada and Japan + You thrive in a fast paced environment whilehaving a flexible workstyle + You have good communication and presentation skills **Required skills to have for the success of this role** + Bachelors degree + Minimum2-5years ofregulatory experience in the medical device industry + Ability to travel up to 15% At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. **If you want to join us in transforming the way healthcareis delivered, visit our career site at** ****************************************** **.** If you wish to find out more about the specific before applying, please visit: **************************************** . As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. #LI-AW1 **Equal Employment Opportunity Statement** Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law. **EEO is the Law** Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at ************************************************************** . **Pay Transparency Non-Discrimination Provision** Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at ************************************************************** . Posted: 2019-09-03 Expires: 2019-10-04 Siemens

Keywords: Siemens, Knoxville , Regulatory Affairs Professional, Other , Knoxville, Tennessee

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