Analyst, Safety Regulatory Reporting and Global Complaints

3 weeks ago

Plymouth, United States TekWissen ® Full time

Position: Analyst, Safety Regulatory Reporting and Global Compliants - Contract

Location: 6000 Nathan Lane N, Plymouth, MN 55442 United States

Duration: 6+ Months, Possible Extension

Job Type: Contract

Work Type: Onsite, Later Remote after 2 weeks training

Shift: ((Mon-Fri)(8.00AM-4.30PM)

Pay Rate: $35-$35.00/hour


Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a, passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. A leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services.


Job Description:

Qualifications:

  • Must be at least 18 years of age.
  • High School Diploma required.
  • Bachelors Degree in Engineering, Medical Sciences, or other related scientific field required.
  • 2+ years experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business preferred.
  • Client FDA Medical Device Reporting and experience with Trackwise Digital preferred.

Work Environment

  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.

Responsibilities:

Position Summary

  • The temporary position is responsible for managing device complaints and adverse events globally.
  • This may include: complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.

Essential Duties & Responsibilities

  • Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.
  • Responsible for creating and submitting regulatory reports to the FDA.
  • Works independently and is accountable for completing task as assigned.
  • Works well in a team to accomplish team goals.

Knowledge & Skills

  • Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
  • Basic computer and software skills.
  • Must be able to communicate effectively with internal and external customers.
  • Demonstrate ability to collect, analyze and interpret complaint and adverse event information.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

  • Safety Analyst

    3 weeks ago

    Plymouth, United States Dawson Full time

    Safety Regulatory Reporting Analyst – Healthcare $35.00 per hourContract through November 2024 Monday-Friday 8:00am – 4:30pmPlymouth, Minnesota – hybrid The temporary position is responsible for managing device complaints and adverse events globally. This may include: complaint initial triage, submitting regulatory reports in accordance with applicable...

  • Product Surveillance Analyst

    1 day ago

    Plymouth, United States GTT, LLC Full time

    Product Surveillance Analyst Contract Duration 12 MonthsJob Duties:Product Surveillance Analyst may perform multiple functions within the postmarket surveillance department.Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on...

  • Analyst, Product Surveillance

    20 hours ago

    Plymouth, United States SMS Staffing Inc. Full time

    Job DescriptionJob DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Analyst, Product Surveillance! Job Title: Analyst, Product SurveillanceJob Location: Plymouth, MN, U.S.A. 55442Job Type: Contract (possible extension or convert to hire)Pay: Starts at $22.00 an hourShift Structure: ONSITE, 8:00 AM - 4:30 PM, Monday to Friday, 40 hours per...

  • Analyst, Product Surveillance

    2 hours ago

    Plymouth, United States SMS Staffing Inc. Full time

    SMS Staffing Inc is Hiring Immediately for a skilled Analyst, Product Surveillance!Job Title: Analyst, Product SurveillanceJob Location: Plymouth, MN, U.S.A. 55442Job Type: Contract (possible extension or convert to hire)Pay: Starts at $22.00 an hourShift Structure: ONSITE, 8:00 AM - 4:30 PM, Monday to Friday, 40 hours per weekThe Role of the Analyst,...

  • Prof III-Regulatory Affairs-General Regulatory Affairs

    22 hours ago

    Plymouth, United States Baxter Full time

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Regulatory Affairs Manager

    3 weeks ago

    Plymouth, United States Custom Search, Inc. Full time

    Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance with applicable laws and regulations in the development, manufacturing, and marketing of products and its subsidiaries’ products, and uses this knowledge to support pre-market and post-market activities and will work closely with Quality...

  • Regulatory Affairs Manager

    3 weeks ago

    Plymouth, United States Custom Search, Inc. Full time

    Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance with applicable laws and regulations in the development, manufacturing, and marketing of products and its subsidiaries’ products, and uses this knowledge to support pre-market and post-market activities and will work closely with Quality...

  • Global Stability Leader

    2 weeks ago

    Plymouth, United States Baxter Full time

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Functional Safety Engineer

    2 weeks ago

    Plymouth, United States New Eagle Full time

    Job DescriptionJob DescriptionPosition DescriptionNew Eagle is a trusted engineering partner and supplier for electronic systems and control software across diverse sectors like automotive, transportation, defense, industrial, aviation, military, aerospace, and off-highway. Specializing in mechatronic controls, we assist developers in managing project...

  • Corporate Financial Reporting Manager

    2 weeks ago

    Plymouth, United States Creative Financial Staffing Full time

    CFS has partnered with a growing manufacturing company that's looking to hire a Corporate Financial Reporting Manager. Our client is a full service producer of complex mechanical products and fabricated structures for military vehicle systems and commercial agricultural equipment that range from complete design services to prototype manufacturing, testing,...

  • Biomedical Engineer

    32 minutes ago

    Plymouth, United States Collabera Full time

    Duties: Candidates will work in a few aspects of our complaints handling system. Will work on complaint handelling. Initially, will work in the lab assisting with returned product root cause investigation and evaluation submission. May also be tasked with assisting complaint handling process: intake, processing, and reporting on product experiences. ...

  • Senior System Safety Engineer

    3 weeks ago

    Plymouth, United States CareerBuilder Full time

    New Eagle is a trusted engineering partner and supplier for electronic systems and control software across diverse sectors like automotive, transportation, defense, industrial, aviation, military, aerospace, and off-highway. Specializing in mechatronic controls, we assist developers in managing project development, supply chain, costs, and outcomes,...

  • Senior System Safety Engineer

    3 weeks ago

    Plymouth, United States New Eagle Full time

    Job DescriptionJob DescriptionNew Eagle is a trusted engineering partner and supplier for electronic systems and control software across diverse sectors like automotive, transportation, defense, industrial, aviation, military, aerospace, and off-highway. Specializing in mechatronic controls, we assist developers in managing project development, supply chain,...

  • Senior System Safety Engineer

    2 weeks ago

    Plymouth, United States New Eagle Full time

    Job DescriptionJob DescriptionNew Eagle is a trusted engineering partner and supplier for electronic systems and control software across diverse sectors like automotive, transportation, defense, industrial, aviation, military, aerospace, and off-highway. Specializing in mechatronic controls, we assist developers in managing project development, supply chain,...

  • Senior Financial Analyst

    2 weeks ago

    Plymouth, United States Gateway Recruiting, INC. Full time

    Job DescriptionJob DescriptionThe Job Opportunity:This position is a key value-added role within Finance that partners with various levels of leadership to drive financial ownership, cost efficiency, and process improvement. This role will be responsible for complex, timely, and accurate financial planning, forecasting, and reporting for the business....

  • Senior Financial Analyst

    2 weeks ago

    Plymouth, United States Gateway Recruiting, INC. Full time

    Job DescriptionJob DescriptionThe Job Opportunity:This position is a key value-added role within Finance that partners with various levels of leadership to drive financial ownership, cost efficiency, and process improvement. This role will be responsible for complex, timely, and accurate financial planning, forecasting, and reporting for the business....

  • Senior Accounting Analyst

    3 weeks ago

    Plymouth, United States Creative Financial Staffing Full time

    SENIOR ACCOUNTING ANALYST JOB DESCRIPTION: Why work here as a Senior Accounting Analyst? Hybrid Office Environment - Two to Three Days per week from home! Good Work/Life balance - it is VERY rare that you will work overtime (the manager has never missed a kids sporting event!) Low Turnover. The average tenure is over 10 years. The manager of this group...

  • Material Analyst

    4 weeks ago

    Plymouth, United States Magna International Inc. Full time

      Job Number: 55417 Group: Magna Mechatronics, Mirrors & Lighting  Division: Mechatronics, Mirrors & Lighting Group Office Job Type: Permanent/Regular Location: PLYMOUTH    Group Description The Mechatronics, Mirrors and Lighting group specializes in automotive technologies that are driving the future of mobility. Combining a deep...

  • Sr Manager, Regulatory Affairs

    4 weeks ago

    Plymouth, MN, United States BAXTER Full time

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...

  • Client Service Intern

    4 weeks ago

    Plymouth, United States FM Global Full time

    FM Global is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions. FM Global helps clients maintain continuity in their business operations by drawing upon state-of-the-art loss-prevention engineering and research;...