Regulatory Affairs Specialist Resume

Posted in Specialist Resume Examples

Dale Perez
1789 High Meadow Lane
Scranton, PA 18503
(111)-506-4297
[email]

Job Objective Regulatory Affairs Specialist seeking position with a well-established organization where my experience can be used for the well-being of the company.

Highlights of Qualifications:

  • Vast experience in Regulatory Affairs & Quality Assurance environment
  • Familiarity with Medical Device Regulations and international Medical Device Reporting
  • Proficient with metrics, process, and software tools
  • In-depth knowledge of radiation testing principles and practices
  • Ability to balance multiple responsibilities on-time and effectively
  • Ability to work closely with people at all levels of the organization
  • Ability to thoroughly analyze and demonstrate due diligence

Professional Experience:

Regulatory Affairs Specialist
Boston Scientific, Scranton, PA
May 2006 – Present

  • Drafted regulatory strategies for new and modified medical devices.
  • Provided Regulatory Affairs feedback and guidance.
  • Submitted regulatory applications and internal regulatory file documentation
  • Reviewed device labeling and advertised materials in adherence with submissions.
  • Developed document packages for regulatory submissions.
  • Developed and submitted applications for relevant State and federal licensing.

Regulatory Affairs Specialist
Advanced BioHealing, Inc., Scranton, PA
March 2003 – April 2006

  • Prepared appropriate information per requirements for domestic and international submissions.
  • Compiled and developed data for registration.
  • Reviewed product complaints.
  • Provided leadership in these areas to ensure compliance.
  • Gathered and developed appropriate information pre requirement for submission.

Education

Bachelor’s Degree in Biotechnology
Sacramento City College, Sacramento, CA


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