Siemens Regulatory Affairs Specialist in Berkeley, California
Regulatory Affairs Specialist
Job Family: Quality Management
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%
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
Seeking a Regulatory Affairs Specialisttocontribute as a key member ofSiemens Healthineers Molecular DiagnosticsQuality Managementteam 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.
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
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 .