Assoc MDR/Vigilance Specialist
1 month ago
Job Title: Assoc MDR/Vigilance Spec
Client: Medical Device Manufacturing Company
Duration: 2 years
Location: Mounds View, Minnesota 55112
Shift: 1st Shift- Hybrid - Mon/Tues on site/in-office, Wed-Fri remote
Job Description:
HM's Top Needs:
- Attention to detail
- Critical thinking skills
- Excellent written communication skills
Education Required:
- Bachelor's Degree
Years' Experience Required:
- 0-2 years
Role Summary:
As an Associate MDR/Vigilance Specialist, you will document and evaluate product feedback and product analysis results to determine complaint status and regulatory reporting status in compliance with US and OUS regulatory guidelines. Compile and submit regulatory agency reports and perform activities to monitor complaint activity, ensuring timely review and follow-up actions related to complaint closure.
Division:
Neuroscience: Develops therapies and healthcare solutions for neurological care, integrating technologies and applying clinical and economic evidence to improve patient outcomes.
A Day in the Life:
Responsibilities include, but are not limited to:
- Apply policies and procedures to comply with FDA and OUS regulations
- Monitor the company's drug or medical device surveillance program
- Evaluate incoming information for Medical Device Reporting and Vigilance reporting eligibility
- Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VR)
- Interface and collaborate with internal and external contacts to collect complaint information efficiently
- Maintain awareness of new products, government regulations, and requirements
- Act as a liaison to develop programs and processes for regulatory reporting
- Perform other duties as assigned
Must Have: Minimum Requirements:
- Bachelor's degree
- High level of computer proficiency (e.g., Microsoft Office, SAP, Siebel, Oracle Clinical)
- 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have:
- Degree in Health Care, Sciences, or Bio-Medical Engineering
- Medical device industry experience
- Strong verbal and written communication skills
- Knowledge of basic anatomy and physiology
- Strong attention to detail
- High level of computer proficiency
Specialist Career Stream:
- Typically an individual contributor with responsibility in a professional discipline or specialty
- Deliver and manage assigned projects, working with stakeholders to achieve results
- May mentor colleagues or direct lower-level professionals
- Majority of time spent delivering and overseeing projects from design to implementation
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 non-complex problems
- 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 focused on self-development
Required Knowledge and Experience:
- Broad theoretical job knowledge typically obtained through advanced education
- Requires a Bachelor's degree (or equivalent for degrees earned outside of the United States)
- 0 years of experience required
-
Assoc MDR/Vigilance Spec
1 month ago
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...
-
Assoc MDR/Vigilance Spec
1 month ago
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...
-
Associate MDR/Vigilance Specialist
1 month ago
Saint Paul, United States Planet Pharma Full time(This is an onsite 24-month contract, with potential to extend/convert, available to people local to the Mounds View, MN area)Pay Rate Range: $24-27/hr. Salary will be commensurate with experienceThere are 7 openings for this positionOur client cannot accept any C2C or candidates who requires sponsorship now or at any point in the future (this includes OPT,...
-
St Paul, United States Planet Pharma Full timeAssociate 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 DegreeYears’ Experience Required: 1+ yearsHours: 40hrs per week - 8am-5pm Hybrid Role: 2-3 days in office HM's Top Needs:Complaint handling &/or medical device experience would be a...
-
Senior Regulatory Affairs Specialist
3 months ago
Saint Paul, United States Collabera Full timeJob DescriptionJob Description· Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use:· Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files...
-
Supplier Compliance Specialist
1 month ago
Saint Paul, United States Innovize Full timeJob DescriptionJob DescriptionJob DescriptionTitle: Supplier Compliance SpecialistDepartment: QualityReports to: Quality ManagementStarting Salary: $84,136+ FLSA Status: Exempt, Full Time Benefits: Full time associates are eligible for benefits the first of the month following 30 days of service. Medical Insurance HDHP, HSA Plan - Employer Contribution of...
-
Sr. Regulatory Specialist
2 weeks ago
St Paul, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Sr. Regulatory Specialist - Electrophysiology Pulsed Field Ablation At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden...
-
Cash Courier Specialist
2 days ago
Saint Paul, Minnesota, United States GardaWorld Full timeJob Summary:GardaWorld is a leading provider of cash management solutions, offering a range of services including secured transportation, cash management, and cash vault processing. We are seeking a highly skilled and experienced Armed Cash Transport Driver to join our team.Key Responsibilities:Transport valuable assets safely and efficiently, adhering to...
-
Aquatic Safety Specialist
1 week ago
Saint Peters, Missouri, United States Gateway Region YMCA Full timePosition OverviewThe Aquatic Safety Specialist is responsible for ensuring the safety and well-being of all individuals utilizing the aquatic facilities. This role requires constant vigilance and proactive engagement in monitoring the pool area.Key ResponsibilitiesMaintain continuous observation of the swimming area to prevent accidents.Familiarize and...
-
Quality System Specialist
3 weeks ago
Saint Paul, United States Innovize Full time $21 - $23Job DescriptionJob DescriptionJob DescriptionTitle: Quality Systems Specialist-Documentation ControlReports to: Quality Systems ManagerSummary: Quality position primarily focused on achieving compliance with Quality System requirements. Works under the direction of the Quality System Manager to implement Quality System requirements for assigned Quality...
-
Production Machinery Operator
1 week ago
Saint Paul, Virginia, United States Tate Inc. Full timeJob OverviewThe Machinery Operations Specialist at Tate Inc. plays a crucial role in the efficient functioning of our production processes. This position requires a comprehensive understanding of all machinery and equipment within the department, as well as the capability to mentor fellow team members on operational procedures.Key ResponsibilitiesAcquire and...
-
Facilities Maintenance Specialist
1 week ago
Saint Peters, Missouri, United States Fairway Management Full timeJob OverviewPosition: Facilities Maintenance SpecialistCompany: Fairway ManagementWork Schedule: Full Time, Monday to Friday, 8am - 5pmCompany Profile:Fairway Management (FWM), a subsidiary of JES Holdings, oversees the upkeep, marketing, and operational management of over 250 residential communities and numerous single-family rental properties. The...
-
Cybersecurity Specialist
1 month ago
Saint Louis, United States EFC International Full timeJob DescriptionJob DescriptionEFC International is a dynamic and forward-thinking organization committed to maintaining the highest cybersecurity standards. We seek a talented and motivated individual to join our team as a Cybersecurity Specialist. This role offers an exciting opportunity to work with cutting-edge technologies and contribute to our...
-
Reliability Engineer II
3 months ago
St Paul, United States LanceSoft Full timeNice to Have: 1. Experience supporting, coordinating and / or leading projects 2. Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA) 3. Experience in development of new or existing medical devices 4. Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA Analytical and Problem Solving Skills a...
-
Immunotherapy Administration Specialist
2 weeks ago
Saint-Dizier-les-Domaines, Nouvelle-Aquitaine, United States Hampton Roads Otolaryngology Assoc Full timePosition OverviewJob Title: Immunotherapy Administration SpecialistDepartment: Allergy ServicesReports To: Office Manager and Allergy Services LeadAvailability: 7:15 AM - 6:45 PM, Monday to FridayPOSITION SUMMARYThe Immunotherapy Administration Specialist is responsible for delivering allergy injections to patients receiving immunotherapy treatments.KEY...
-
Healthcare Support Specialist
1 week ago
Saint Charles, Missouri, United States SSM Health Full timeMore than just a job, it's a vocation. Job Overview: In collaboration with a team of healthcare professionals, the Clinical Partner I plays a vital role in delivering a range of nursing care services to patients. Key Responsibilities: Receives patient care assignments from the supervising registered nurse (RN) and initiates tasks based on...
-
Checkpoint Operations Specialist
1 week ago
East Saint Louis, Illinois, United States PROFESSIONAL TRANSPORTATION SERVICES INC Full timePosition OverviewLocationARS - CENTREVILLE - Centreville, ILCompensation$14.00 per hourRole SummaryWe are seeking dedicated Gatekeepers in Centreville, ILStarting Compensation: $14/hrAs a Checkpoint Operations Specialist, your primary responsibility will be to support operational activities by managing the entry and exit of vehicles and personnel at the...
-
Healthcare Observation Specialist
5 days ago
Saint-Brieuc, Bretagne, United States Compass Group Careers Full timeJoin Our Healthcare TeamAre you interested in pursuing a career in the healthcare sector? Compass Group Careers is on the lookout for committed individuals to become Patient Monitoring Associates. This position entails providing vigilant visual and auditory monitoring of designated patients under the supervision of a Registered Nurse (RN). If you possess a...
-
Safety and Security Specialist
1 week ago
Saint Albans, Vermont, United States DSI Security Full timeOverviewAt DSI Security, we offer more than just a paycheck; we provide a fulfilling career experience. Our core values and motto, "Do What You Say You Will Do," resonate through every level of our organization, from our esteemed clients to our dedicated security personnel.Joining DSI is not merely about employment; it’s about embracing a lifestyle that...
-
R&D Engineer
1 week ago
St Paul, United States Laborie Medical Technologies Corp Full timeWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...