Siemens Reg Clinical Affairs Spec 5 in Newark, Delaware
Reg Clinical Affairs Spec 5
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 200288
Primary Location: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Senior 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/healthineers
Prepares regulatory submissions for in vitro diagnostic products. Represents Regulatory Affairs on Product Development Teams. Develops and executes global regulatory strategy for assigned projects and interacts with regulatory authorities. Ensures compliance to US FDA Quality System Regulations and internal Quality System. Reviews and approves product labeling and advertising/promotional material. Provides regulatory assessments for product changes. Maintains awareness of global regulatory legislation and assesses impact of changes to the business. Consults and provides training related to regulations and regulatory requirements. Participates in audits and inspections by regulatory authorities and certification/accreditation bodies. As a subject matter expert, mentors less experienced regulatory professionals.
Significant experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers preferred. Knowledge and experience with global registrations and development of medical devices. Clinical Laboratory experience preferred. Strong leadership, interpersonal, communication and organizational skills required.
Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities. Must be able to set priorities as well as adapt to changing priorities.
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 .