Person, Clothing, Apparel, Clinic, Lab Coat, Coat, Hospital, Nurse, Sleeve

Project Manager/ Regulatory Affairs

IMPORTANT ALERT FOR JOB APPLICANTS!
Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information from applicants. Be aware that Bio-Rad strictly adheres to these hiring practices.

Project Manager/ Regulatory Affairs

  • 2020-16899
  • Benicia, California, United States

The RA Project Manager IV is responsible for the strategic leadership, management and oversight of Global Regulatory Affairs Projects to enable revenue growth and enhance compliance, like the IVDR project.  The RA Project Manager IV will manage IT and non-IT projects to improve business processes for the RA team and interfacing departments.  The Project Manager VI will facilitate project team formation, meetings, goals, timelines, appropriate scope while utilizing and deploying Lean project management.  The RA Project Manager IV interfaces with global teams and will be responsible for global implementation of business processes and systems.      

Responsibilities

This important position will support several business systems/processes including reporting product data through the Global Data Synchronization Network, business systems for global health authority registrations and data analytics to drive registration decisions.  This position will train and support the RA team members using these systems and collect inputs for improvements.  This position will also document the business processes in SOP’s and Work Instructions.

  • Participate in large projects focused on improving RA operations and processes.
  • Collaborate with RA Project Managers and RA Management team on initiatives to create new reports, metrics and dashboards based on business needs
  • Recommends scalable practices for the future of the organization to further enhance business measurements using statistical based analysis to drive data based conclusions.
  • Trouble shoots, reports on, and tests new system/tool functionality.
  • Assists in UAT testing and script writing.
  • Facilitates communication between technical and business teams in the identification and resolution of technical issues.

Qualifications

  • Bachelor’s degree is required. Advanced degree preferred. 
  • 10+ years’ relevant team/project leadership experience is required with a strong preference for demonstrated ability to utilize Lean Project Management tools.
  • Demonstrated ability to develop options and pathways to improve business processes considering internal and external customer requirements, risk and business needs.
  • Experience in Project Management preferred.
  • Record of successful project team membership.
  • Experience with master data, business systems, IT projects or change management is a plus.
  • Experience working in a regulated industry is required.
  • Strong Internal and External Customer Orientation and Focus
  • Effective Communication Skills (Written and Verbal)
  • Experience working with Global Teams
  • Track record of influencing and consensus building.

 

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

 

Agency Non-Solicitation: 

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. #LI-LE2

 

 

Other People Viewed

Production Operator I - Temp (Day Shift) 2020-17120 Santa Rosa California United States Santa Rosa, California, United States Manufacturing/Production Clean room production support position.  Executes a variety of tasks that includes operation of basic equipment, packaging of products, visual inspections, and completing required documentation following Good Documentation Practices.  Responsibili...
Production Operator I - Temp (Swing Shift) 2020-17121 Santa Rosa California United States Santa Rosa, California, United States Manufacturing/Production Clean room production support position.  Executes a variety of tasks that includes operation of basic equipment, packaging of products, visual inspections, and completing required documentation following Good Documentation Practices.  Responsibili...
Production Operator I - Temp (Graveyard Shift) 2020-17122 Santa Rosa California United States Santa Rosa, California, United States Manufacturing/Production Clean room production support position.  Executes a variety of tasks that includes operation of basic equipment, packaging of products, visual inspections, and completing required documentation following Good Documentation Practices.  Responsibili...
Diversity & Inclusion Program Manager 2020-17219 Hercules California United States Hercules, California, United States HR Bio-Rad has an immediate need for a Diversity and Inclusion (D&I) Program Manager. This position is located in our corporate headquarters, located in Hercules, CA.The D&I Program Manager will assume a significant role in ensuring that we a...
Field Service Engineer II 2020-14636.1 St. Louis Missouri United States St. Louis, Missouri, United States Field Service/Support Bio-Rad Laboratories (https://www.bio-rad.com/) has an exciting opportunity for a Field Service Engineer. This is a remote position servicing the St. Louis, Missouri area. Bio-Rad was founded over six decades ago and has continued to provide the h...
R&D Manager I 2020-17170 Hercules California United States Hercules, California, United States Research & Development Bio-Rad is looking for a Software Development Operations Manager who is excited about growing and leading the software infrastructure team. The team supports the infrastructure and tools for software desktop and embedded device development in Life...

Apply Now 

Alert me about jobs like this

Not You?

Thank you

Meet a Bio-Radian

Hear what it's like to work at Bio-Rad.

5_stars.png

“Bio-Rad Rocks! ... ”

Scientist (Current Empl.) Plano, TX

" ... In continuing the mission of Advancing Science and Improving Lives, you have the opportunity to make contributions to products that improve life on the planet Earth in meaningful ways. I love the get-the-job-done environment in Plano and being part of a team that delivers."

More About Us

Apply Now

Alert me about jobs like this

Not You?

Thank you