Regulatory Affairs Specialist Resume
Here is the Regulatory Affairs Specialist Resume example:
Dale Perez
1789 High Meadow Lane
Scranton, PA 18503
(555)-555-5555
[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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