Siemens Careers

Regulatory Project Manager- Point of Care

Norwood, Massachusetts
Project Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Siemens Healthineers
Requisition Number: 241214
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 15%

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
 
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
 
For more information, please visit: http://www.usa.siemens.com/healthineers


Job Description:

Regulatory Program Manager, POC


The Regulatory Program Manager for Point-of-Care (POC) is fully responsible for project execution to establish compliance to the European In-vitro Diagnostics Regulation (IVDR) at POC. This covers all phases of the project through the mandatory compliance deadline. The position is responsible to achieve measurable implementation for all products planned to be placed on the European market after the compliance deadline.


During project execution, this position keeps the cross-functional team focused on achieving the expected project results in a timely manner. The individual facilitates communications between team members, manufacturing sites and senior management to ensure business goals are met.


 


As a Program Leader, responsibilities include:


  • Lead a cross functional team through a disciplined process of iterative planning and risk mitigation, action-oriented and timely execution, and team-based problem solving
  • Own, track and execute to the integrated project plan that guides critical activities and resources
  • Drive fast project decision making and trade-off assessments
  • Apply basic and advanced methods for problem solving and process optimization
  • Interface with functional managers for resource management
  • Interface with the larger “Euro 20/22” Healthineers program to assure consistency and information flow with Erlangen QT
  • Manage project communications to all stakeholders including escalating hurdles and bottlenecks to senior management
  • Drive implementation of required process changes at all impacted sites


  • Ensure compliance of the project execution, e.g. process adherence and completeness


  • Foster continuous improvement mindset within project team(s) and department


 


Skills and Attributes:


  • Ability to coordinate across all disciplines of the business as they are needed for demonstrating IVDR compliance


  • Self-motivated initiative and discipline. The role requires self-direction and self-advocacy, knowing when to ask for help and when to provide guidance to team members


  • Experience in lean methods like Six Sigma, Agile or Business Systems for operational excellence


  • Strong analytical skills and data driven mindset

  • Experienced in anticipating risk and working on counter-measures

  • Excellent communicator, mediation skills, capable of working under changing conditions

  • Understanding of IVDR requirements and interfacing with Notified Bodies

  • Detailed knowledge of Quality Systems, including ISO 13485


 


Required Experience, Knowledge and Expertise:


  • Bachelor’s degree in an analytical or operational major; Masters is preferred

  • 10-15+ years of general business experience, with at least 7 years working in an FDA-regulated environment

  • 5-10 years of progressively responsible experience working and leading in a project management environment

  • Direct experience planning and executing complex projects, with remote resources and technical complexity


  • Experience in regulatory submissions to Notified Bodies and Health Authorities (e.g. FDA)
  • Ability to travel within US  and outside of the country


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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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