Clinical Regulatory Affairs
Location: Mounds View Minnesota
Description: Randstad Pharma is hiring Clinical Regulatory Affairs right now, this vacancy will be placed in Minnesota. Detailed specification about this vacancy opportunity kindly read the description below. Position Description
Perform detailed investigation of adverse events and generate medical device rationale or Medical Device Report for all products.
Interface with Company’s manufacturing, regulatory, quality, clinical, ventures, device registration, technical/patient services, international facility, and legal representatives, as needed.
Conduct follow-up investigation for reported MedWatches and assist in data collection and reporting for trending purposes.
Contribute in continuous improvement initiatives.
Maintain awareness of new product! s, government regulations and requirements.
Position ! Responsibilities
Receive and document product events reported by customers and field representatives
Request additional information as needed for complete understanding of the event
Assess events for regulatory reportability and potential impact to patient safety and business operations
Completes and submits regulatory reports within the timeframes mandated by the FDA
Investigates complaints by gathering sufficient data from clinical staff, Company field representatives, internal employees, clinicians, and laboratory analysis
Uses good documentation practices to record all information related to the events into the complaint database
Maintain files that meet the QSR and Corporate requirements
Review and modify department procedures as necessary to stay current with corporate standards
Develop internal systems, methods, and procedures to maintain compliance and support post-market surveillance
Evaluate and recommend changes to current systems
Serve on multi-business teams to evaluate system changes/upgrades
Write and communicate position papers pertaining to clinical perspective for regulatory reporting, including consulting with outside clinical resources and other subject matter experts
Maintain enhanced technical knowledge of devices in area of responsibility
Educate and train others on the proper method of reporting complaints
Prepare and participate in Notified Body and FDA inspections
Routinely analyze and evaluate work and computer processes to improve work processes and service to customers
Position Requirements
Bachelor’s Degree
Certification/Licensure or Registered Nurse preferred
3-5 years of related work experience
Specialized Knowledge; 3+ year’s medical device industry
Knowledge of 21 CFR Part 820 - Quality System Regulations
Knowledge of 21 CFR Part 803 - Medical Device Reporting
Kn! owledge of 21 CFR Part 806 - Corrections and Removal
Knowledge of 45 CFR Parts 160 and 164 - The Privacy Rule, HIPAA Statute
Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, cardiovascular therapies and technologies
Solid understanding and application of business concepts and practices
Excellent knowledge of word processing, spreadsheet, database and graphics presentation applications
Advanced oral and written communication skills
Record management
Exercises judgment in selecting innovative, practical methods to achieve problem resolution
Works under minimal supervision
Establishes and cultivates an extensive network of support to facilitate completion of assignments
Strong team and interpersonal skills
Working knowledge of worldwide adverse event reporting requirements (21 CFR 803, QSR 820, MEDDEV 2.12-1, Article 25! 3 of Pharmaceutical Affairs Law, etc.) is preferred
Cardiac Catheterization/Electrophysiology Lab, Device (Cardiac Rhythm) Clinic, and/or Operating Room experience is preferred
Benefits
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Flexible Spending Account
Life and AD&D Insurance
Relocation Assistance
- .
If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Randstad Pharma.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Wed, 08 Jan 2014 18:36:12 GMT