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Assoc MDR/Vigilance Spec - Exempt
HireTalent
🇺🇸 United States
On-site
Entry level
4 months ago
- medical terminology
4 months ago
Not enough detail in this posting to match
Ability to apply critical thinking to make sound decisions
Excellent communication skills (oral and written), with strong organizational and analytical skills (problem solving, critical thinking)
Knowledge of basic anatomy, physiology, and medical terminology
Strong attention to detail
JOB DESCRIPTION
No Spotlight Call
BR: ***/hr
HM's Top Needs:
1. Ability to apply critical thinking to make sound decisions
2. Strong attention to detail and organizational skills
3. Excellent communication skills (oral and written)
Associate MDR/Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Neurovascular products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from any and all regulatory bodies). Associate MDR/Vigilance Specialist are expected to learn the Neurovascular products along with the internal procedures and processes and apply the concept across a variety of complaint inputs. Associate MDR/Vigilance Specialist may have the opportunity to support continuous improvement activities and cross-functional collaboration as needed by the business.
Education Required: Bachelor’s Degree in Bio-Sciences, engineering
Years’ Experience Required: 0-2 years experience in medical device/pharmaceutical industry
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes
Work Location:
Do they need to be local to any MDT office and if so where? Mounds View
Does this person need to be on site? If so, full time or part time? 4 days out of the week
Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – job at this level is focused on self-development. Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0-2 years of experience required.
Assoc MDR/Vigilance Spec - Exempt · HireTalent