Job Description

Quality & Regulatory Documentation Expert
Job Number: 19-08083
Be a part of a company that supports life-changing healthcare solutions. Eclaro is looking for a Quality & Regulatory Documentation Expert for our client in Rocklin, CA.
Eclaro’s client is a leading manufacturer of lab materials, technology and service supporting the Life Science field. If you’re up to the challenge, then take a chance at this rewarding opportunity!
  • Review and process labeling including IFUs, ensuring label verification and IFU reviews are completed in a timely manner
  • Responsible for reviewing Document Change Controls to ensure proper adherence to procedures, policies, standards, and regulation requirements
  • Ensure labeling is processed, formatted, issued, and made effective accurately
  • Participate in labeling and marketing reviews
  • Audit changes for accuracy and completion
  • Provide guidance and communication to Originators in order to share best practices and resolve change issues and/or discrepancies; promptly respond to questions and issues
  • Work with Originators in following-up, analyzing and helping to resolve open change control issues.
  • Work with management to ensure training curriculum are up to date.
  • Lead/participate in projects/assignments that support labeling efforts and department/company goals.
  • Bachelor's degree required
  • Must have GMP experience; minimum 3 years' experience in document control in biotech or related regulated industry
  • Solid computer skills; must be proficient in Microsoft Office Suite and Adobe
  • General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards
  • General knowledge in labeling requirements for regulated products
  • Experience with EDMS systems, such as ManGo and/or Doc Compliance (eDoc) System
  • Experience with sap knowledge
  • Excellent written and verbal skills
  • Experience working in ISO 13485 and/or FDA regulated laboratory
  • Knowledge of Unique Device Identification (UDI) requirements and process
  • Ability to work independently and manage multiple tasks
  • Knowledge of cGMPs related to labeling
  • Demonstrates sound and accurate judgment
  • Excellent organizational, interpersonal, and communications skills
  • Understands, supports, and communicates Company mission, vision, and values
  • Understands and follows the requirements of the Quality system
  • Initiate actions as necessary to prevent occurrence of any non-conformance related to the product, process, or the Quality system
  • Identify and document any problems related to product, process, or the Quality system
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro 
If interested, you may contact:
Maria Castañeda
Maria Castañeda | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.


Application Instructions

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