Medical Device Reporting (MDR) Specialist
Location: Mounds View Minnesota
Description: Humera is looking of Medical Device Reporting (MDR) Specialist right now, this vacancy will be placed in Minnesota. More complete informations about this vacancy opportunity kindly read the description below. Humera has an opportunity for 2 Medical Device Reporting Specialists! These year-long, contract opportunities are working for our client, a medical technologies compa! ny. Our client is committed to innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease. These positions are working with the company's compliance investigation area, which involves working across the organization on different products and patient experiences.
Perform detailed investigation of adverse events and generate medical device rationale or reports for all products
Interface with company manufacturing, regulatory, quality, clinical, ventures, device registration, technical services, international faculty and legal representatives
Conduct follow up investigations
Contribute in continuous improvement initiatives
Maintain awareness of new products, government regulations and requirements
Complete recording to ensure compliance with regulatory standards
Communicate back to customers about their questions and concerns
Undergraduate degree is required; Nursing Degree pref! erred
Minimum of 1 to 3 years of regulatory affairs experi! ence within the medical devise industry
Advance degree in related field knowledge and skills/competencies
Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states, cardiovascular therapies and technologies
Demonstrated ability to achieve objectives and milestones through identification and implementation of work plans and measurements
Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing
Demonstrated ability to identify and adapt to shifting priorities and competing demands Demonstrated ability to maintain composure in difficult circumstances
Demonstrated ability to identify and overcome obstacles
Ability to constructively respond to feedback from customers and coworkers
High attention to detail and accuracy
Optimal Critical Thinking / Analytical Skills
Clinical Background with basic Product Knowledge (EPG, Programmer, A! nalyzer, ICD, IPG) Preferred
Intuitive knowledge of clinical questions to obtain the complaint incident details needed for an adequate complaint investigation
Healthcare, Nursing or Clinical Research background preferred
Excellent oral and written communication skills and strong teamwork ethic
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Humera.
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, 10 Apr 2013 19:53:25 GMT