Siemens Careers

Regulatory Affairs Specialist

Berkeley, California
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Strategic Procurement
Requisition Number: 227559
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid 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 world’s 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/healthcare




Job Description:

Seeking a Regulatory Affairs Specialist to contribute as a key member of Siemens Healthineers Molecular Diagnostics Quality Management team located in Berkeley, CA. The Regulatory Affairs Specialist is responsible for representing regulatory affairs on project core teams, submitting EU technical files, technical file updates and renewals for in-vitro diagnostics and medical devices.  In addition, the successful candidate will participate on the internal auditing team and support rest of world registrations, interactions with the FDA as well as participate in company-wide compliance projects.

 

The successful candidate will report in to the position site Regulatory Head within the business unit.

 

Responsibilities

  • Provide regulatory guidance for and participate in new product development and product changes
  • Interact with and coordinate with company employees world-wide to support business unit objectives
  • Drive regulatory submissions, regulatory agency communications and other tasks for compliance purposes including MDSAP.
  • Work with the Regulatory Affairs team in the writing and filing of appropriate FDA submissions
  • Review and approve project DHF documentation for compliance with EU and FDA regulations.
  • Supports the decision making process on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industry.
  • Support updating IVD products to meet the IVD Regulation.

 

Required Knowledge/Skills, Education, and Experience

  • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience
  • 5 - 8 years of experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above
  • Experience working as a regulatory affairs representative on assay, hardware and/or software product core teams
  • Highly developed writing and interpersonal skills
  • Experience interacting and communicating efficiently with global regulatory agencies, working on multiple teams and working independently
  • Working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc)
  • 10% travel required

 

Preferred Knowledge/Skills, Education, and Experience

  • BS degree in Engineering, Molecular Biology or Biochemistry preferred
  • Prior experience in in-vitro diagnostics highly preferred
  • Prior experience with EU regulations for instruments and software preferred
  • Knowledge of IVDD Harmonized Standards preferred
  • RAPS Regulatory Affairs Certification preferred

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