PM (Regulatory Affairs)

PM (Regulatory Affairs)
Locations:East Walpole, Massachusetts
Job Family: Project Management
English (US)
Job Description
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 213219
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Division Description:
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
Job Description:
Position Overview
Key support position, working with RA, QA, China Manufacturing Operations Core team (DRACO) and element teams to facilitate resolution of Regulator/compliance issues associated with the Siemens Manufacturing expansion project in Shanghai. Areas of focus include; Test method validation, Product Performance Evaluations, Product Technical Requirements development, CFDA Clinical Trial support, CFDA submission support and Design control, both at the Walpole and Shanghai facilities.
Key purpose of this position is to own RA interface for China Manufacturing Core team. Will be single point of contact for RA and Operations in Walpole and Shanghai.project Draco.
Tasks include; Support DRACO Core team, Wave transfer Element team and Coordinate Tech Transfer SME activity as WAVE schedule requires regarding RA/CFDA obstacles and tasks. Develop strategies, drive decisions, develop plans and implement actions that will drive on-time completion of DRACO Master and Wave schedules.
Individual will be specifically responsible for;
+ Establish single point of contact for DRACO and RA.
+ Develop tracking tool for issues/projects/timelines
+ Interact with TECTRN SMEs to resolve RA/CFDA/compliance issues
+ Interact with other DRACO functions to resolve RA/CFDA/compliance issues
+ Support preparation for PPE builds
+ Support preparation for clinical trials and Type Testing
+ Communicate status of issues/projects a regular basis to DRACO Core team
Desired Skills
Understanding of the assay architecture and design of immunoassays.
Have experience in design control, risk management and CAPAs.
Be able to give presentations and partake in high level reviews in a clear and concise manner.
Good understanding of CFDA and RA regulations.
Previous exposure to RA environment and Design controls.
Demonstrate ability to analyze problems in a structured and systematic manner.
Goal driven with the proven ability to interpret data and to troubleshoot and resolve technical issues.
Excellent quantitative skills and knowledge of statistics enabling the ability to work cross functionally with statisticians.
Ability to multi-task and to support multiple project teams in cross functional settings.
Excellent organizational, oral and written communication skills.
Proficient in Microsoft Office applications.
Position Requirements
BS in chemistry, biology or biological sciences, with 6-10 yrs industry experience, or MA/MS with 3-6 yrs industry experience
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 .

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