Regulatory Reporting Analyst-Gobal Compliants
3 weeks ago
Note--- This role will be onsite for the first few weeks for training. From there, it will largely be remote, but may need to come onsite time to time as the business needs. This is why we're looking for candidates in the Minneapolis and Salt Lake City areas.
Must-Have:
- Bachelor’s 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.
- US 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:
- The temporary position is responsible for managing device complaints and adverse events globally.
- This may include complaint initial triage, submitting regulatory reports by applicable regulations, referring potential safety cases to applicable departments, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.
Essential Duties & Responsibilities
- • Responsible for evaluating complaints from a 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 tasks 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.
We are fine to provide any required information if any job seeker wants before submitting the resume for an interesting job.Company DescriptionFastnet Software International Inc is a NY-based legitimate staffing organization. \r
We are fine to provide any required information if any job seeker wants before submitting the resume for an interesting job.
-
Safety Analyst
3 weeks ago
Plymouth, United States Dawson Full timeSafety 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...
-
Analyst, Product Surveillance
22 hours ago
Plymouth, United States SMS Staffing Inc. Full timeJob 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
4 hours ago
Plymouth, United States SMS Staffing Inc. Full timeSMS 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,...
-
Product Surveillance Analyst
1 day ago
Plymouth, United States GTT, LLC Full timeProduct 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...
-
Senior Accounting Analyst
3 weeks ago
Plymouth, United States Creative Financial Staffing Full timeSENIOR 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...
-
Analyst, Product Surveillance
1 hour ago
Plymouth, United States Experis Full timeAnalyst, Product Surveillance North Plymouth MN United States 12-month contract with high possibility of extension Pay rate: $24/hr. Job description: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred. Strong analytical and investigative skills. Familiarity with complaint handling investigations, medical...
-
Senior Tax Analyst
3 days ago
Plymouth, United States Creative Financial Staffing Full timeSenior Tax Analyst Company Overview: Our client is a dynamic and growing company known for its innovative approach and commitment to excellence. We are seeking a talented and experienced Senior Tax Analyst to join their thriving team. This company offers a positive and collaborative work environment, excellent benefits, and ample opportunities for...
-
Business Analyst
4 weeks ago
Plymouth, United States Federated Service Solutions Full timeJob DescriptionJob DescriptionBusiness AnalystFounded in 2004, Federated Service Solutions (FSS) is passionate about helping businesses do business better. Our focus is end-to-end technology equipment and infrastructure solutions for large retailers throughout the United States and beyond. Our services include, but are not limited to, infrastructure cabling,...
-
Cargo Claims Analyst
2 weeks ago
Plymouth, United States United Road Services Full timeJob DescriptionJob DescriptionThe Cargo Claim Analyst will support the Risk Management/Quality Department in analytical, reporting and record keeping functions. The primary responsibility of this position is to analyze each cargo claim based on investigation findings and documentation to determine claim validity to for best resolution. The Cargo Claims...
-
Workstation Analyst
2 weeks ago
Plymouth Meeting, United States Apex Systems Full timeJob#: 2018369 Job Description: Apex Systems has partnered with a Regional Health System to fill a Workstation Analyst opportunity in Muncy, PA. Ideal candidates will come from a strong customer service and technical support background. They must be comfortable working in a hospital setting. If interested, send an updated resume to [email protected] , along...
-
Business Analyst
3 days ago
Plymouth, United States Federated Service Solutions Full timeJob DescriptionJob DescriptionFounded in 2004, Federated Service Solutions (FSS) is passionate about helping businesses do business better. Our focus is end-to-end technology equipment and infrastructure solutions for large retailers throughout the United States and beyond. Our services include, but are not limited to, infrastructure cabling, skilled...
-
Senior Financial Analyst
2 weeks ago
Plymouth, United States Gateway Recruiting, INC. Full timeJob 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 timeJob 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....
-
Sr ERP Systems Analyst
3 weeks ago
Plymouth, United States Daikin Applied Full timeMake your mark at the world's largest HVAC company! Why You'll Love Working for Daikin: We're a group who operates with a people-centered mindset, believing in the unlimited potential of each employee, with a goal of driving our company to its fullest potential. Our goal is to "Perfect the Air We Share". We do this through cutting edge innovation &...
-
Healthcare Business Analyst
2 weeks ago
Plymouth Meeting, United States ProgenyHealth LLC Full timeJob DescriptionJob DescriptionDescription:Job RoleProgenyHealth is seeking an Healthcare Business Analyst to contribute to health data integrations of proprietary neonatal software. The successful candidate will lead interface, interoperability and EDI development, and will work alongside senior developers and systems analysts in support of interface...
-
Healthcare Compliance Manager
4 weeks ago
Plymouth, United States Ophthalmic Consultants of Boston Full timeJob DescriptionJob DescriptionOCB is currently seeking a Healthcare Compliance Manager. They will be based out of our Plymouth office and travel to other offices as necessary. The ideal candidate will have prior clinical experience, successfully worked across all levels of an Ophthalmic, sub-specialty or general medical practice, with significant experience...
-
Healthcare Compliance Manager
1 week ago
Plymouth, United States Ophthalmic Consultants Of Boston Full timeOCB is currently seeking a Healthcare Compliance Manager. They will be based out of our Plymouth office and travel to other offices as necessary. The ideal candidate will have prior clinical experience, successfully worked across all levels of an Ophthalmic, sub-specialty or general medical practice, with significant experience and exposure to compliance,...
-
Senior Director, Finance Systems
6 days ago
Plymouth, United States AdaptHealth corp. Full timeDescription Position Summary: Senior Director, Finance Systems & Architecture will lead and oversee the technical deployment of financial systems, architecture, and related processes, ensuring the optimization of financial operations. Overall responsibilities for the finance systems, solution design, and experience with key platforms such as Oracle Cloud ERP...
-
Principal Engineer
1 week ago
Plymouth, United States Daikin Applied Full timeMake your mark at the world's largest HVAC company. Why You'll Love Working for Daikin: We're a group who operates with a people-centered mindset, believing in the unlimited potential of each employee, with a goal of driving our company to its fullest potential. Our goal is to "Perfect the Air". We do this through cutting edge innovation & sustainability...
-
Senior Financial Analyst
7 days ago
Plymouth, United States Helm Full timeDescription: Currently seeking Finance Professionals with a drive for the next step in their career. We are a growing mid-size company in need of someone with the right skill set and experience holding the responsibility for internal and external data and reporting. A professional with a strong curiosity to dive into the numbers and suggest process...