Regulatory Compliance Specialist Resume

Samantha Gray

North Highlands CA 95660

(916) 987-6543

[email protected]

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Job Objective

Seeking a position as Regulatory Compliance Specialist in which my abilities and experience can aid in the growth of the company.

Highlights of Qualifications:

  • Huge experience with laboratory equipment and testing procedures
  • Profound knowledge of FDA regulations, pharmaceutical GMPs
  • Wide knowledge of Validation concepts, procedures, protocols and requirements
  • Familiarity with pharmaceutical manufacturing process, facilities and equipments
  • Ability to develop, organize and manage multiple tasks
  • Ability to make and act upon sound, independent judgment
  • Ability to identify problems and provide solutions
  • Excellent organizational, record retention and time management skills
  • Strong decision making and creative problem solving skills
  • Excellent interpersonal and communication skills

Professional Experience:

Regulatory Compliance Specialist

Stryker, Faith, SD

May 2006 – Present

  • Initiated Health Hazard Evaluation documents in document control system.
  • Communicated potential actions to internal stakeholders.
  • Collected partially completed Health Hazard Evaluation documents from manufacturing location.
  • Analyzed complaints to determine MDR / MDV report ability to FDA / Competent Authorities.
  • Oversaw reporting of recall affectivity to corporate entities.
  • Took part in process improvement and automation.

Regulatory Compliance Specialist

Owens & Minor Distribution, Inc, Faith, SD

March 2003 – April 2006

  • Provided validation support of all process and system validations.
  • Prepared, implemented and monitored Quality System policies and procedures.
  • Directed investigations and resolution of non-conformances and CAPA
  • Assuredall relevant regulatory, safety and special handling training and information are delivered.
  • Assisted in the timely and proper filing of required forms for DEA, FDA, State.


Bachelor’s Degree in Manufacturing Engineering

Kentucky State University, Frankfort, KY