Regulatory Affairs

21CFR Part 11, EU-MDR, 820, ISO, Regulatory Filing, Risk Assessment, CAPA
Full Time
$60,000+
Travel required to 100%.

Job Description

RevereIT LLC has openings for Entry Level Positions.

The Job Duties include but are not limited to the following:

System Analyst (Regulatory Affairs)

  1. Evaluate the safety, efficiency, and effectiveness of biomedical equipment
  2. Review and approve design specifications and design verification and validation protocols; facilitate and participate in design reviews; develop quality engineering deliverables.
  3. Perform root cause analysis and conduct statistical analyses to quantify risk using statistical analysis software
  4. Preparing regulatory or compliance documentation, create risk assessment, preliminary hazard analysis documents
  5. Responsible for coordinating the Risk management activities of medical device as per ISO Standards and FDA Regulations.
  6. Develop and maintain Requirement Traceability Matrix (RTM) to cross reference the functionality to the required Verification and validation documents, Writing and reviewing DHF files.
  7. Ensuring the quality system remains in compliance to CFR 820 and ISO 13485.
  8. Support technology transfer of processes/articles by providing complete, accurate quality documentation which includes sampling plans, process controls, test methods, engineering studies and measurement system analysis.
  9. Perform time and motion studies, failure mode effects analysis, and other quality engineering studies as applicable.
  10. Collaborate Regulatory Department regarding national product submissions and regulatory topics (510(k)s, labeling and promotional materials, complaints handling, FDA Medical Device Reporting).
  11. Complete Preliminary and Final Regulatory Assessments and Regulatory Strategies.
  12. Participate in implementation of electronic submission database for global submissions that confer with requirements of EU e-CTD format.
  13. Prepare and Submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications.
  14. Prepare 510(k) s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy.
  15. Compile materials required in worldwide (including 21CFR, European Medical Device Directives, and other key global regions) Pre-market and Post Market Regulatory Affairs submissions, License renewals and annual registrations.

Minimum Bachelor s Degree in Engineering Discipline such as Mechanical,/Chemical/ Electrical/ Biomedical /Biotechnology/ Electronics /Manufacturing / Industrial Engineering/ Technology Management / Engineering Management / Information Technology / Information Systems or related & Regulatory Affairs /Biology/Chemistry/Biotechnology/ Pharmacy /Pharmacology or related field.

 

Candidates will be accommodated in the related area of position/s depending on the requirements of the Clients.

 

Relocation to Client Sites with short notice is a MUST. Likely candidates will be tested on their general ability to perform the above tasks. E-Mail resumes to hr@revereit.com.

 

Validation Analyst (Regulatory Affairs)

  1. Interpret FDA regulations or changes and ensure that they are communicated through corporate policies and procedures.(21CFR820, ISO 13485 and ISO 14971).
  2. Establish programs/methods to evaluate analytical testing, equipment, facilities, precision measurements, accuracy measurements, and performance testing.
  3. Develop documents and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) ,Test Method Validation protocols and Traceability Matrix in accordance with standard operating procedures (SOP)
  4. Perform data analysis for process performance and process capability to determine variability.
  5. Initiate CAPA for deviation, non-conformance and non-compliance issues.
  6. Perform statistical analysis like Gage R&R, ANOVA and MINITAB to determine root cause for deviations
  7. Determination and documentation of corrections/removals
  8. Ensure quality plans, design and development plans, V&V plans and protocols comply with company requirements, FDA regulations and industry quality standards.
  9. Metric generation and communication for quality/compliance and management reviews
  10. Prepare Requirement Specifications of Systems for Validation Process.
  11. Develop Regulatory Deliverable timeline and schedule for each assigned Project. & design control activities.
  12. Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
  13. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products such as Installation, Operation, Performance Qualifications.
  14. Maintain databases for validation activities, test results, or validated systems and procedures.
  15. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes

Degree Required:

Minimum Bachelor s Degree in Regulatory Affairs / Biology / Chemistry / Biotechnology/ Pharmacy / Pharmacology or Engineering such as Mechanical / Chemical / Electrical / Biomedical /Biotechnology / Electronics /Manufacturing/ Industrial Engineering / Technology Management/Engineering Management or related./

 

Candidates will be accommodated in the related area of position/s depending on the requirements of the Clients.

 

Relocation to Client Sites with short notice is a MUST. Likely candidates will be tested on their general ability to perform the above tasks. E-Mail resumes to hr@revereit.com.

Dice Id : 10429725
Position Id : 5877537
Originally Posted : 1 year ago
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