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RA Operations Manager - $10,000 Hiring Bonus

RA Operations Manager - $10,000 Hiring Bonus

  • 2022-28400
  • Hercules, California, United States

Bio-Rad is seeking a Regulatory Affairs Operations Manager.  This role will be responsible for developing the Operations team to manage key processes that help support the Regulatory Affairs teams.

 

This position is eligible for a $10,000 HIRING BONUS: 

 

  • Bonus offered for a limited time only.
  • Bonus applicable to specific positions as labeled.
  • Bonus recipients must be employed at the time of payout.
  • Bonus payout after 30 days of employment with Bio-Rad.
  • Bonus offered to direct hires only. Agency hires and internal transfers are not eligible.
  • 12 months repayment clause.

Responsibilities

  • The Regulatory Operations Manager is responsible for regulatory operations for Global RA/QA to meet business needs including the following functions:
  • Regulatory Systems Development and Administration (e.g. Regulatory Information Management System, SAP, iICE, etc) 
  • Regulatory surveillance & implementation planning.
  • Annual registration planning, budgeting and tracking execution.
  • Regulatory project management to support registration activities for key company projects.
  • Improvement and automation of regulatory processes.

Qualifications

  • Bachelor’s degree in Biology, Chemistry, Molecular Biology, Clinical Laboratory Science or related field.  Advanced degree is recommended.
  • Regulatory Affairs Certification and PMP certification are preferred.
  • 8+ years’ relevant regulatory operations leadership including supervisory and management experience is required, or an equivalent combination of education and experience working in an FDA QSR and ISO 13485 regulated environment including experience with in vitro diagnostic (IVD) medical devices.
  • Prior experience working within a matrix environment across multiple sites and organizations.
  • Extensive knowledge and application of FDA, CE Mark, MDSAP, GUDID/UDI and global regulatory requirements for diagnostic products. 
  • Prior experience in regulatory surveillance to support implementation of new standards and regulations.
  • Experience in registration planning and budgeting working with the commercial and business teams for registration initiatives.
  • Extensive systems knowledge including prior experience with SAP.
  • Strong Customer Orientation and Focus.
  • Effective Communication Skills (Written and Verbal).

 

Vaccination Requirement:

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

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-KD2 

 

 

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