Siemens Regulatory Technical Specialist in Knoxville, Tennessee
Regulatory Technical Specialist
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Diagnostic Imaging
Requisition Number: 223029
Primary Location: United States-Tennessee-Knoxville
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
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
Responsible for collection, preparation and assembly of documentation required for various submissions to relevant Regulatory Authorities (FDA, BOP, etc.). Process product complaints including conducting the investigation and writing the final report. Assist with internal audits, third-party audits and exception/investigation closure. Work with CMO partners to manage Quality and Regulatory topics associated with their product.
· Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals.
· Proactively identifies potential regulatory issues and recommends solutions to Regulatory Affairs management.
· Participate in or assist senior regulatory associates in development of regulatory submissions within assigned products.
· Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
· Interacts with internal and external partners as necessary to support product development.
· Monitors related corporate activities for regulatory compliance, including research and development/manufacturing.
· Product Complaint Management
· Assist with internal and external audits
· Assist with Exception/Investigation Closure
· Liaison with CMO partner regarding Q&R related topics
· Conducts and analyzes regulatory research to understand past precedence and the current competitive landscape. Evaluate and communicate impact of relevant regional regulations, guidance documents, current regulatory environment and competitor labeling.
· Drives priorities and key issues as defined by regulatory management
· Conversant and able to influence colleagues in regulatory strategies and compliance issues
· Educates internal stakeholders on implications of regulations.
· Supports the preparation of responses to complex questions and comments from regulatory agencies.
· Develops timeline for responding to inquiries from regulatory agencies and ensures issues are addressed in a timely manner.
· Identifies and appropriately communicates potential risks.
3-4 years of experience in Regulatory Affairs and/or Quality Assurance in the pharmaceutical industry. Prior experience with regulatory submission, complaint investigation and CMO Quality Relationship management desired.
BS/MS in a scientific discipline. A degree in Chemistry or Microbiology is preferred.
High standard of professional ethics, integrity and trust.
Excellent oral and written communication skills.
Excellent planning, organizational and prioritizing skills.
Consistently high professional image and demeanor.
Strong interpersonal /group skills; capable of working collaboratively with colleagues in all functions.
Attention to detail and accuracy.
Able to effectively multi-task.
Ability to interpret, understand and comply with domestic and international regulatory requirements.
Ability to coordinate information from cross-functional disciplines.
Flexible in responding to changing project priorities.
Exercise good judgment in decision-making and sharing of sensitive information.
Strong understanding of the drug development and regulatory process.
Knowledgeable in the general principles of nonclinical development, CMC and clinical development.
Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks.
Responds effectively to meet management objectives.
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 .