Siemens Dir, Regulatory Affairs in Newark, Delaware
Dir, Regulatory Affairs
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 201404
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Master'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/healthineers
Manage submissions for obtaining and maintaining regulatory approvals and licenses in those markets addressed by product development teams overseen by the CC/Specialty Products PLM.
Interface with a variety of functional groups to provide regulatory guidance regarding the management of issues throughout the product life cycle, including labeling requirements, registration requirements and timing, and expectations of the regulatory bodies.
Monitor and communicate new regulatory requirements to the affected functional groups through coordination with HC QT and International RA team.
Develop strategies to ensure proactive planning to be compliant with new requirements and new regulations in the US, EU, and Canada, and set priorities for those activities.
Participate and function as a key RA leader in the CC/Specialty Products PLM
Proactively plan and staff new product development teams (CORE Teams) so that resources are aligned to meet the business priorities
Manage team of RA specialists as they execute new product registrations in all markets as planned within the scope of the CORE Team responsibilities
The ideal candidate will possess
A strong knowledge and practical experience in regulations for MDs and IVDs, particularly as they relate to U.S., Canada, and EU requirements
Strong relationships with other functional groups in the BA involved in the management of a product’s life cycle (R&D, manufacturing, sales, marketing, supply chain, labeling, global product support, quality and regulatory)
Strong relationships with the functional heads as represented in the PLM
Demonstrated strong technical skills and knowledge of IVDs
Broad knowledge of quality management system and principles
Strong team building and leadership skills
Effective time management
Ability to prioritize and juggle multiple projects and thrive under pressure
Strong communication and presentation skills
Experience with trade associations, knowledge of harmonized standards , rulemaking procedures and commenting process
Management experience and demonstrated competence in personnel development, including at least 4 years’ experience with medical devices; preferably IVDs
Other desirable qualities:
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.
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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/PayTransparencyNotice_JRFQA508c.pdf .