Medical Quality
Resume:
Debbie Miranda,
Clear Lake, South Dakota 57226
Phone Number; 605-***-****
************@*****.***
Summary:
Demonstrated track record of providing direction, project management,
structure, and strategy for regulatory goals. Experience with a team in
writing regulatory submissions for successful regulatory approvals for
medical devices in the United States. Monitoring and researching new
regulation and amendments to existing regulation and providing regulatory
and compliance guidance.
Professional background
Empi DJO Company
Orthopedics
Electrotherapy/Iontophoresis Devices
2009-Present
Sr. Regulatory Specialist
. MDR/Vigilance reporting to FDA, to international agencies including
Canadian Health, EU Competent Authorities, and to Notified Body as
required. Responsibility for assessments of adverse event reports to
determine if reportable or complaints, MDR, Vigilant reporting.
. Host all external audits with Notified bodies and FDA
. Reclassification of Iontophoresis medical devices from class III to
class II experience
. NDA and IND submission experience
. Recall, field corrections experience
. Submissions, license renewal and annual registrations
. Set up FDA eSubmissions for electronic MDR reporting
. Set up a working project for UDI labeling
. Write and set up manuals for class I, II, and III Iontophoresis
medical devices
. CE marking
. Successful with international registrations
. Device labeling, translations and marketing literature review
. All customs issues
Maxtec, Inc.
Oxygen Sensors, blenders, mixers, etc. for respiratory care
2007-2009
Director Regulatory/Quality
. Ensure that all departments involved in the manufacture and sale of
product comply with procedures designed to achieve and maintain the
product and company quality standards
. Compiles all materials required in submissions, license renewal and
annual registrations.
. CE marking
. Successful with international registrations.
. Compile device master records, technical files, design dossiers, FDA
and European submission documents, and/or any other related
documents/reports, ensuring timely submissions to Notified Body to
meet Company product(s) and regulatory requirements, and compliance to
all approved licenses.
. Review Change Control requests, deviation requests, quality system
reports for adequacy and compliance with company and regulatory
requirements.
. Responsibility for Deviation Reports in compliance with the Code of
Federal regulations.
. Write and maintain procedures relating to the Regulatory affairs
function, the preparation and presentation of quality reports, data
and Key Performance Indicators for management reviews.
. Evaluation of customer complaints, ensuring complaint reports are
closed out in accordance with the approved procedure.
. All MDR reporting.
. Labeling and marketing review.
. Participate in the development, management, and maintenance of the
Company's Quality System to meet the requirements of US FDA, ISO
13485:2003, MDD, CMDCAS and all other applicable quality and
regulatory standards.
Boston Scientific
Implantable Stents for Neuro and Cardio
2006-2007
Sr. Product Analyst
. Expert in TrackWise software for complaints, MDR, Vigilant reporting.
. Clarify what should and should not be reported to FDA in training
sessions.
. Develop functional metrics indicators for tracking and trending and
able to interpret.
. Review all product complaint reports and review all MDR's before
submitted to FDA.
Lumenis Lasers
Medical and Aesthetic Lasers
2004-2006
Regulatory Affairs/Quality Engineer
. Conduct training to all departments as required for software changes
and new form implementation (MFG-PRO, TrackWise).
. Responsible for writing scripts for software validations and
verifications for TrackWise
. Worked with IT as one of the project managers, to develop the quality
complaint system and set up TrackWise
. Coordinate and perform internal audits of departments to QSR, ISO
14001 and ISO 13485
. Manage initial and follow-up reports for Regulatory issues in a timely
manner.
. Responsible for writing and implementing the procedures for safety
(MDR Reporting) complaints and product/performance complaints,
reviewing and evaluating.
. Investigations Analyst (root cause) for all injury complaints and
product/performance complaints.
. Proficient with MDR (Medical Device Recording) and vigilance
reporting.
Certifications
Member of Regulatory Affairs Professional Society (R.A.P.S.)
RAPS Regulatory Affairs Certificate for Medical Devices
Academic Excellence certification
Presidents List (Deans List) certification
Training/Seminars
International Import and Export
APICS, Just in Time
Steven Covey "Seven Habits for Highly Effective People
ISO 13485:2003
R.A.P.S Seminars and Training
Rapport Leadership Program
Six Sigma Training
Education
Trade Tech adult education classes, SLC Utah, basic Science and Chemistry.
Western International University Behavioral Science 2 years.
Associates degree, National American University.
Technical Skills
UniPoint, Lotus Notes, Act, Access, Excel, Word, MAPIC's, MFG-PRO,
Microsoft Project, (Windows 2000), Microsoft Office, Adobe, Illustrator 10,
Visio, Track-Wise, Visual Manufacturing, FileMaker, SAP, Expandable,
Alfresco, Documentem, Power Point and other Presentation Software, Page
Maker, MSC-KlickFile, etc.
Contact this candidate