Data Entry Medical Device
Resume:
BIH ANYE
CONTACT
********@*****.***
Minneapolis, MN
PROFILE
Knowledgeable Biochemist and Diagnostic Medical Technologist with over 8 years of industry working experience in various functions, including Regulatory, Clinical technology, operations, and R&D. Strongly reliable and focused Regulatory analyst with experience in medical device review, evaluation, and reporting. Superb multitasker with the ability to handle multiple projects efficiently and accurately. Effective independent worker as well as excellent coordinator with other members of a regulatory affairs team.
SKILLS
- Extensive experience in quality assurance and regulatory affairs work environments
- Superior expertise in medical device regulations and reporting
- Excellent proficiency with software tools and metrics
- Strong knowledge of radiation testing practices and principles
- High skills in maintaining professional relationships with all levels of staff
- Outstanding analytical and problem-solving abilities
EXPERIENCE
MDR/Vigilance Specialist – Medtronic Mounds View
Jan 2021- Nov 2023
• Electronically process medical device complaints from various sources to submit to the FDA.
• Ensure adequate and accurate investigations, data entry and paperwork in order to complete events for submission.
• Maintain a working knowledge of product lines and regulations applicable to event processing.
• Collaborate internally and complete special projects
• Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
• Complete electronic submission of MDRs to the FDA.
• Ensure accurate data entry, scanning, and retention of documents to complete event files.
• Support internal systems, methods, and procedures to maintain compliance.
• Develop and maintain product knowledge of CRHF products.
• Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling.
• Complete projects as assigned and required specific to post-market quality and complaint handling.
Skills: Quality Control · Regulatory Requirements · Complaint Management · Complaint Investigations
Regulatory Report Analyst II at Abbott
May 2020- Dec 2021
• Understanding and awareness of the EU and other international regulatory requirements to ensure compliance.
• Receives and processes customer complaints in accordance with FDA, EU MDR Vigilance Reporting, MEDDEV and other regulatory requirements.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.
• Drive continuous improvements through observation, measurement, and root cause analysis/resolution
• Develop and maintain tools to manage team activities workflow
• Knowledge and experience in the following areas: new product development, regulatory submission, compliance, complaint handling, medical device risk management processes, and regulatory policies.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Managed educational projects in device knowledge
• Ability to work with both short and long-term deadlines.
• Excellent proficiency with software tools and metrics
Registered Vascular Tech(RVT) at Cedar Valley Cardiovascular Center 2019-2020
• Handling product complaints and assessments with medical devices
• Maintained organized, safe, and efficient work area to minimize accident chance.
• Performed data analysis and provided recommendations to achieve results.
• Performed non-invasive Vascular ultrasound testing on adults, and pediatrics patients.
• Operated in compliance with all appropriate regulatory agencies and safety requirements.
• Resolved routine issues and escalated non-standard or critical issues to appropriate departments.
• Contributed to team discussions, new project initiatives and executions to advance progress.
Application Chemist at Cargill 2018 –2020
• Execute hands-on laboratory work by developing skin care, hair care and oral care products following good laboratory practices.
• Conduct studies and testing for understanding properties and interactions of raw materials.
• Interpret results of laboratory studies conducted.
• Maintain thorough and accurate documentation and reports.
• Set product specifications and write manufacturing procedures
• Conduct stability testing and other evaluation techniques-based studies for efficacy assessment of raw materials.
• Comply with rules on EHS (environment, health and safety) and food safety.
• Maintain and up-keep of the laboratory following processes.
• Maintain the raw materials library which will involve ordering raw materials, putting-in the chemical inventory system, maintaining paper-work and keeping tab on expiry dates.
• Set-up procedures for operating instruments, set up testing methods on instruments, design test protocols and record results
Biochemical Quality Assurance Scientist at General Mills 2017 –2018
• Testing reagents for company use according to procedure
• Create and maintain documentation and maintain databases as needed
• Maintain accurate and complete records of work performed such as daily production checklist on all equipment.
• Recognize and take action to correct apparent discrepancies found in product/process inspection. Notify quality manager when discrepancies are found.
• Complete daily GMP Pre-Operational checklist and GMP daily inspection sheets.
• Verify product codes for accuracy and completeness.
• Operate all equipment in a safe and efficient manner to meet or exceed OSHA standards.
• Follows SOP, GMP and Federal and State regulations
Biochemical Research Scientist at Bio-Techne
2015 –2017
• Prepare conjugate proteins, antibodies, enzymes and microparticles for manufacturing and research.
• Testing reagents for company use according to procedure
• Assisted with lab upkeep, cleaning, labeling, stocking, ordering materials, documenting data and maintain accurate measurements for batches.
• Perform luminex assays and Q-kit ELISA assays to check for quality performance of product, maintain accurate documentation of results, and maintain assay database.
• Run Luminex 100/200, BioPlex and MagPix Instruments along with troubleshooting assay problems and assist in transfer of new products from Development.
EDUCATION
Jackson College
2019-2020
Vascular Ultrasound Technologist
St Cloud State University
2013-2015
Bachelor of Science in Biochemistry, Minor in Psychology
Century College
2009-2013
Associates in Art
EXPERTISE
Medical Device:
• EPIQ
• MDR Reporting
• MDV reporting
• TUV reporting
• Inbox management
• SAP Knowledge
• Complaint Handling
• Excel and Microsoft Office
• Device tracking Log
• Product return
RVT:
• Profound knowledge of the human anatomy
• Knowledge to ultrasound Technology
• Medical implantable devices
• Sterile scanning techniques
Biochemistry:
• Protein Synthesis/Purification
• Peptide Mapping
• Gel Electrophoresis
• Protocol Buffers
• PCR and HPLC
• Fluorescence Spectroscopy
• UV/Vis
• pH meter and Titration
• Atomic Absorption
• Staining and DNA extraction
Microbiology:
• Aseptic and Sterile techniques
• Optical microscopy
• Bacterial staining
• Plating methods (streak, spread,
pour)
• Enumeration and Identification of bacteria
• Media and Buffer preparation
• Plaque assay
• Gram stain
Instrumentation & Technologies:
• Infrared Spectroscopy Instrument
• FT-IR
• Spectrophotometers
• Nuclear Magnetic
• Resonance Spectroscopy
• Microsoft Office
• Chromatography
• Mass spectrometers
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