30 days old

Senior Regulatory Technical Specialist (4)

Norwood, MA
**Senior Regulatory Technical Specialist (4)**

Locations:Norwood, Massachusetts

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Point of Care

**Requisition Number:** 220552

**Primary Location:** United States-Massachusetts-Norwood

**Assignment Category:** Full-time regular

**Experience Level:** Senior level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 10%

**Division Description:**

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the worlds largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthineers

**Job Description:**

**Siemens US Talent Acquisition**

**Senior Regulatory Technical Specialist (4)**

**Position Overview**

**_Are you looking to be a part of something exceptional? If working for_** **_Siemens Healthineers in the Point of Care (POC) Business Area_** **_peaks your interest, then this opportunity is for you!_** We are looking for **_an experienced Regulatory Affairs leader to join our enthusiastic and collaborative team._**

**_The selected individual will:_**

+ Represent Quality / Regulatory Affairs on product development Core Teams

+ Independently develop regulatory strategies, plans and submissions, and identify solutions for POC product lines

+ Report to Director, Pre-Market Clinical & Regulatory Affairs, Quality Technology, Point of Care Business Area


+ Represent Quality / Regulatory Affairs on product development Core Teams and interact with multiple functions/departments, including R&D, Validation Services, Clinical Affairs, Medical Affairs, Biostatistics, Program Management, Quality Systems, and others

+ Independently develop regulatory strategies, plans and submissions, and identify solutions for POC product linesusing historical knowledge, legal counsel and FDA's current guidances and regulations pertaining to medical devices

+ Provide Quality / Regulatory design guidance to ensure correct testing / validation requirements are met to support regulatory submissions as well as a robust Design History File (DHF)

+ Independently generate regulatory submissions [510(k)s, Pre-Submissions, Global Dossiers, Technical Files, etc.]

+ Liaise with Regulatory Agencies to ensure successful outcomes are achieved

+ Review promotional material and device labeling for regulatory compliance

+ Work cross-functionally with Post-Market/International Regulatory Affairs and Quality Management, as workload permits, to support efforts in these areas

**Required Knowledge/Skills, Education, and Experience**

+ BS/BA in life sciences or related discipline, or advanced degree, or equivalent combination of education and experience

+ Regulatory Affairs Certification (RAPS)

+ Demonstration of a minimum of 8 years of successful experience in Regulatory Affairs, preferably with a global manufacturer of medical devices, and successful performance of responsibilities presented above; **experience in** **_in vitro_** **diagnostics highly preferred**

+ Strong working knowledge of global medical device regulations including quality design requirements during medical device development

+ Advanced working knowledge of FDA regulations for Class II devices

+ Strong knowledge of international regulations and submission requirements for medical devices

+ Experience developing and executing strategy to successfully market medical devices

+ Well versed in QSR Design Control requirements and in educating project teams on these requirements

+ Experience with managing and preparing regulatory submissions, such as Pre-Submissions and 510(k)s, and related interactions with various regulatory agencies

+ Experience reviewing product labeling, including advertising/promotional materials

+ Demonstration ofeffective written and oral communication skills with internal / external customers from various departments / levels and with regulatory authorities ( _examples of several authored documents/communications requested_ )

+ Exceptional attention to detail with strong organizational and technical writing skills

+ Ability to successfully work on a multidisciplinary team in a fast-paced, dynamic environment

+ Ability to manage multiple projects simultaneously

+ Ability and willingness to travel, domestically (rarely internationally), less than 10%

**Preferred Knowledge/Skills, Education, and Experience**

+ Experience with IVDs used in point-of-care settings and CLIA waiver petition

+ Experience preparing submissions to Notified Body for approval of Self Test products


**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 https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


  • Engineering
  • Financial Services
  • Legal
  • Manufacturing / Production
  • Marketing
  • Healthcare

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Senior Regulatory Technical Specialist (4)

Norwood, MA

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Norwood, MA

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