Siemens Healthineers Regulatory Affairs Professional II Knoxville United States of America

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Now’s our time to inspire the future of healthcarentogether.SiemensnHealthineers is a leading global medical technology company with over 170 yearsnof experience and 18,000 patents. More than 48,000 dedicatedncolleagues in over 70 countries are driven to shape the future of healthcare.nWe stand with our customers around the world to support them in delivering highnquality care to their patients. An estimated 5 million patients across thenglobe benefit every day from our innovative technologies and services innthe areas of diagnostic and therapeutic imaging, laboratory diagnostics andnmolecular medicine, as well as digital health and enterprise services. This isnwhat truly matters to us. Join our team now at SiemensnHealthineers as a Regulatory Affairs Professional II. This position is locatednin Knoxville, TN.This is a role well suited to an ambitious professional, looking for thennext step in their career. As a Regulatory Affairs Professional II, you will benresponsible for:n You will be responsible for then compilation, submission and maintenance of 510(k) pre-market notificationsn and international regulatory filings.n You will serve as the Regulatoryn representative in project development n teams to develop a global regulatory strategy to ensure timelyn market access of new productsn You will coordinate worldwiden product licensing activities including the gathering of data and then submission of registration documents to in-country Siemens Regulatoryn Representatives n You will ensure promotional materialn are compliant with the product regulatory clearances/approvalsn You will stay current on globaln regulatory requirements and will be engaged in the implementation of newn regulationsnThis position may suit you best if you are familiarnwith what is below, and would like to do develop your career withnHealthineersn You have demonstrated an excellentn working knowledge of FDA 510(k) pre-market notification requirementsn through successful submissionsn You have an in-depth understandingn of EU medical device requirements (MDD and MDR)n You have a general understandingn of  Quality System Requirements (FDAn QSR and ISO 13485)n You have a working knowledge of then medical device regulations in China, Canada and Japann You thrive in a fast pacedn environment  while having a flexiblen workstylen You have good communication andn presentation skillsnRequirednskills to have for the success of this rolen Bachelor’s degree n Minimum 5 – 8 years of regulatoryn experience in the medical device industryn Ability to travel up to 15%nAt Siemens Healthineers, we value those who dedicate their energynand passion to a greater cause. Our people make us unique as an employer in thenmed-tech industry. What unites and motivates our global team is the inspirationnof our common purpose:  To innovate fornhealthcare, building on our remarkable legacy of pioneering ideas thatntranslate into even better healthcare products and services. We recognize thatntaking ownership of our work allows both us and the company to grow. We offernyou a flexible and dynamic environment and the space to move beyond yourncomfort zone to grow both personally and professionally.If you want to join us in transforming the way healthcarenis delivered, visit our career site at ****If you wish to find out more about the specific beforenapplying, please visit: ****As an equal-opportunity employer we are happy to considernapplications from individuals with disabilities.#LI-BI1Organization: Siemens HealthineersCompany: **MEMBERS ONLY**SIGN UP NOW***..Experience Level: Experienced ProfessionalJob Type: Full-timeEqual Employment Opportunity StatementSiemens 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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.EEO is the LawApplicants and employees are protected under Federal law from discrimination. To learn more, Click here.Pay Transparency Non-Discrimination ProvisionSiemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.California Privacy NoticeCalifornia residents have the right to receive additional notices about their personal information. To learn more, click here.,qualifications:UNAVAILABLE,responsibilities:UNAVAILABLE,skills:UNAVAILABLE,workHours:UNAVAILABLE,jobBenefits:UNAVAILABLE,datePosted:2020-04-24T00:00:00 0000,employmentType:UNAVAILABLE,educationRequirements:UNAVAILABLE,salaryCurrency:USD,baseSalary:{@type:MonetaryAmount,currency:USD,value:{@type:QuantitativeValue,value:0,minValue:0,maxValue:0,unitText:YEAR}},validThrough:2021-04-24T22:23:00.000Z,industry:UNAVAILABLE,hiringOrganization:{@type:Organization,name:Siemens,sameAs:****States of America}}}

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