Associate Medical Device Reporting/Vigilance Specialist

4 weeks ago


St Paul, United States Planet Pharma Full time

Associate Medical Device Reporting/Vigilance Specialist.

Length: 6-month

Pay Rate: ~$26.50 - $27.00/hr.

Location: Mounds View, MN OR Lafayette, MN

Education Required: Bachelor's Degree

Years’ Experience Required: 1+ years

Hours: 40hrs per week - 8am-5pm

Hybrid Role: 2-3 days in office


HM's Top Needs:

  1. Complaint handling &/or medical device experience would be a plus.
  2. Strong analytical skills.
  3. Strong communication skills


Responsibilities:

  1. Application of end-to-end complaint handling process with focus on product analysis and investigation summaries.
  2. Writing & reviewing investigation summaries that meet compliance requirements.
  3. Collaborating with key stakeholders involved in product analysis and investigation summaries.


Description:

Associate MDR/Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Endoscopy products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies).


A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Receive and assess product comments to determine need for complaint handling record.
  • Document required information in Global Complaint Handling (GCH).
  • Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting:
  • Field Personnel
  • Health Care Providers
  • Patients or other initial reporters
  • Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the company brand.
  • Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.
  • Initiate, complete regulatory reports for timely submission to FDA and other regulatory bodies.
  • Determine if investigation is necessary. If investigation is necessary, determine:
  • Potential cause and contributing factors to the alleged event.
  • Device relationship.
  • If formal device investigation is necessary.
  • Summarize the results of any investigation.
  • Escalate complex issues to management.
  • Execute other projects as assigned.


Qualifications

Must Have: Minimum Requirements

  • Bachelor's degree with 0 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation


Nice to Have

  • High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
  • 0-2 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
  • Degree in Health Care, Sciences, or Bio-Medical Engineering
  • Strong attention to detail
  • Knowledge of basic anatomy, physiology, and medical terminology
  • Knowledge of:
  • 21CFR, Section 820, Quality System Regulation
  • 21CFR Section 803, Medical Device Reporting
  • ISO 13485, Quality Systems, Quality Management Systems
  • 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations
  • AIMD Directive: 90/385/EEC
  • IVD Directive: 98/97/EC
  • MDD Directive (Council Directive 93/42/EEC for Medical Devices)
  • PC 1998-783 - Canadian Medical Device Regulation (CMDR)
  • Complaint handling experience or customer service/technical support experience (0-2 years)
  • Strong analytical skills (problem solving, critical thinking)
  • Excellent communication skills (oral and written), with strong organizational and analytical skills
  • Ability to work independently or in a team setting


  • St Paul, United States Planet Pharma Full time

    -2 year contract, pay $26.50-27/hrIn this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In...


  • Saint Paul, United States Three Point Solutions Full time

    Job DescriptionJob DescriptionJob Title: Assoc MDR/Vigilance SpecClient: Medical Device Manufacturing CompanyDuration: 2 yearsLocation: Mounds View, Minnesota 55112Shift: 1st Shift- Hybrid - Mon/Tues on site/in-office, Wed-Fri remoteJob Description:HM's Top Needs:Attention to detailCritical thinking skillsExcellent written communication skillsEducation...


  • Saint Paul, United States Planet Pharma Full time

    -2 year contract, pay $26.50-27/hrIn this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In...


  • St Paul, United States LEXION Medical Full time

    LEXION Medical is a world leader in the design and manufacturing of advanced technologies for pneumo-management, gas conditioning, and smoke evacuation for minimally invasive surgical procedures. Our mission is to provide innovative technologies that help patients return to their normal, productive lives faster. Role DescriptionThis is a full-time on-site...


  • Saint Paul, United States LEXION Medical Full time

    LEXION Medical is a world leader in the design and manufacturing of advanced technologies for pneumo-management, gas conditioning, and smoke evacuation for minimally invasive surgical procedures. Our mission is to provide innovative technologies that help patients return to their normal, productive lives faster. Role DescriptionThis is a full-time on-site...

  • Clinical Specialist

    2 days ago


    St Louis, Missouri, United States Calyxo Full time

    Job SummaryCalyxo, Inc. is a leading medical device company seeking a highly skilled Clinical Specialist to join our team. As a Clinical Specialist, you will play a critical role in providing clinical product support and training to surgeons and medical staff.Key ResponsibilitiesProvide clinical case coverage and training to surgical teams to ensure good...

  • Principal Engineer

    1 month ago


    St Paul, United States Luminary Group LLC Full time

    Luminary Group is currently partnering with a leading medical device business in the USA and seeking a highly skilled and experienced Principal Engineer to join their team. As a Principal Engineer, you will provide technical leadership and expertise in the development and implementation of medical device solutions. This is a 6 to 12-month full-time...


  • Saint Paul, Minnesota, United States Luminary Group Full time

    Job OverviewLuminary Group is proud to partner with a leading medical device business in the USA, and we are currently seeking a highly skilled and motivated Program Technical Lead to drive the technical direction and successful delivery of complex medical device projects.Key ResponsibilitiesTechnical Leadership: Provide technical guidance, mentorship, and...


  • St Louis, Missouri, United States Shockwave Medical Full time

    Job Title: Area Vice President, Sales**About the Role**Shockwave Medical, a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, is seeking an experienced Area Vice President of Sales to lead our sales team.**Key Responsibilities**Build and develop a high-performing sales team...

  • Automation Specialist

    4 weeks ago


    St Paul, United States Insight Global Full time

    Must-Haves: Associate’s degree with a focus on automation OR controls, robotics.Knowledge of basic electronics and hands-on wiring of electronic systems (from schooling or in the workforce).1+ years of experience in Ladder Logix/Allen-Bradley PLC Programming.Pluses:1+ years of experience in Logix5000, Studio 5000, Factory Talk View with a PackML.3+...

  • Technical Writer

    4 weeks ago


    St Paul, United States Intellectt Inc Full time

    Role: Technical Writer - II (Medical Device)Location: St. Paul, MN - 55117Duration: 12 Months (Possible extension) 100% Onsite role.Skills Looking For:- Help the engineers in defining features, process and requirements.- Ensure all the different requirement writers maintain a similar style guide.- Read and help with technical reviews.- Support all...


  • Saint Paul, Minnesota, United States Aerotek Full time

    Job SummaryAerotek is seeking a skilled Medical Device Assembler to join our team in a clean room environment. As a Medical Device Assembler, you will be responsible for manufacturing a variety of different styles of French catheters, including basic assembly of catheter components, stringing catheters, reflow, visual inspection, and final packaging of the...

  • Technical Lead

    2 months ago


    Saint Paul, United States Luminary Group Full time

    Job DescriptionJob DescriptionLuminary Group is currently seeking a highly skilled and experienced Technical Lead with expertise in Azure for our medical device client. As a Technical Lead, you will be responsible for leading a team of developers and engineers in the design, development, and implementation of medical device solutions utilizing Azure cloud...


  • St. Paul, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...


  • St. Paul, United States Murata Electronics Full time

    Regulatory Compliance Specialist Location: US Murata Viosis a global medical device company dedicated to...


  • St Louis, United States BJC Full time

    Additional Information About the Role40 hours per week Dayshift 8:00am-4:00pm OverviewBJC Medical Group is the multi-specialty physician organization of BJC HealthCare and includes over 600 doctors and advanced practice providers who are affiliated with the top-ranked hospitals in the area. Since 1994, BJC Medical Group has provided access to the world's...


  • St Louis, Missouri, United States Prime Recruitment Full time

    Job DescriptionWe are seeking a highly motivated and experienced Sales Representative to join our team at Prime Recruitment. As an Associate Territory Sales Manager, you will play a key role in expanding our sales team in the medical device industry.In this role, you will be responsible for selling our company's medical devices and educating healthcare...


  • St. Paul, United States Abbott Laboratories Full time

    Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...


  • St Paul, United States Boston Scientific Full time

    Recruiter: Spencer Gregory Hale Reg Affairs Specialist II - CRM You'll discover a place where you can have meaningful purpose, improving lives through your life's work. Our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and...


  • Saint Paul, Minnesota, United States Aerotek Full time

    Job SummaryAerotek is seeking a skilled Medical Assembly Specialist to join our team. As a Medical Assembly Specialist, you will be responsible for assembling and packaging medical devices in a clean room environment.Key ResponsibilitiesAssemble and package medical devices, including catheters and catheter components, in a clean room environment.Use small...