Sample Regulatory Compliance Specialist Resume

Posted in Specialist Resume Examples

John Esquivel
886 Leroy Lane
Faith, SD 57626
(222)-967-7684
[email]

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.

Education

Bachelor’s Degree in Manufacturing Engineering
Kentucky State University, Frankfort, KY



Create your own professional looking resume for free using our resume builder!