Siemens Regulatory Technical Specialist 3 in Berkeley, California
Regulatory Technical Specialist 3
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Strategic Procurement
Requisition Number: 222612
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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
The open position is within the Regulatory Affairs group which is part of the Quality Management team for Molecular products located in Berkeley, CA. The successful candidate would be responsible for representing regulatory affairs on project core teams, creating, coordinating and submitting 510(k)’s, original PMAs, PMA addendums, supplements, 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 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.
• Create Regulatory Planning for US and Global product submissions/registrations
• 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
• Guides the writing and filing of appropriate FDA pre market 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.
• Act as liaison with FDA and other regulatory agencies and site if needed
Required Knowledge/Skills, Education,and Experience
• Minimum BA/BS in scientific discipline
• RA representative on assay, hardware and software product core teams
• Highly developed writing and interpersonal skills
• 10% travel required
• Ability to interact and communicate efficiently with global regulatory agencies, work on multiple teams and work independently
• Working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc)
Preferred Knowledge/Skills, Education,and Experience
• BS degree in Engineering, Molecular Biology or Biochemistry preferred
• Prior experience in in-vitro diagnostics highly preferred
• Knowledge of IVDD Harmonized Standards preferred
• RAPS Regulatory Affairs Certification preferred
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 .