Regulatory Affairs Associate

6 days ago

Mounds View, United States Select Source International Full time
Job DescriptionJob Description

Position: Regulatory Affairs Associate (Hybrid Position)

Location: Hybrid Position Mounds View, Minnesota 55112

Duration: 24+ months with possible extension

Job Description 
Responsibilities for this role include reviewing product events from a variety of sources to determine the complaint status and create the complaint record in the complaint handling system.  This role is also responsible for determining the regulatory reporting status, completing the regulatory report, and ensuring timely submission.  Responsibilities of this role also include conducting follow-up with internal and external contacts to ensure complete complaint information is obtained as well as evaluating incoming information for Medical Device Reporting and Vigilance Reporting eligibility.    

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. 

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

  • Regulatory Affairs Specialist

    5 days ago

    Mounds View, Minnesota, United States Select Source International Full time

    Job OverviewSelect Source International is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our team, you will be responsible for reviewing product events, determining complaint status, and creating complaint records in our complaint handling system.Key Responsibilities:Review product events from various sources to...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mountain View, California, United States BioLink 360 Full time

    Job Title: Principal Regulatory Affairs SpecialistJoin BioLink 360, a leading medical device company, in a hybrid position based in San Jose, CA. We are seeking a highly experienced Principal Regulatory Affairs Specialist to support our regulatory submissions and compliance efforts.About the RoleWe are looking for a seasoned regulatory affairs professional...

  • Regulatory Affairs Manager

    4 weeks ago

    Mountain View, California, United States HeartFlow Full time

    Job Title: Sr. Manager, Regulatory AffairsAt HeartFlow, Inc., we are seeking a highly skilled and experienced Sr. Manager, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the company's medical devices comply with regulatory requirements worldwide.Key Responsibilities:Manage worldwide...

  • Regulatory Affairs Manager

    1 month ago

    Mountain View, California, United States HeartFlow Full time

    Job Title: Sr. Manager, Regulatory AffairsAt HeartFlow, Inc., we are revolutionizing precision heart care with our cutting-edge technology. We are seeking a highly skilled Sr. Manager, Regulatory Affairs to join our team and play a critical role in ensuring the successful development and market entry of our medical devices.Job Summary:The Sr. Manager,...

  • Associate MDR/Vigilance Specialist

    3 months ago

    Mounds View, United States Redbock - an NES Fircroft company Full time

    Associate MDR/Vigilance Specialist (24 month contract // Hybrid in Mounds View, MN): Mon/Tues on site/in-office, Wed-Fri remoteTop 3 things the manager is looking for: Medical Device Reporting experiencePrevious healthcare experienceMedical device industry experience Top 3 Tasks in Scope for this role: Review incoming complaints from the fieldGo back out to...

  • Associate MDR Vigilance Specialist

    4 days ago

    Mounds View, Minnesota, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title: Associate MDR Vigilance SpecialistLocation: Mounds View/Hybrid 2 days Onsite (Wed & Thursday)Duration: 2 yearsJob Summary:We are seeking a highly skilled Associate MDR Vigilance Specialist to join our team at Integrated Resources, Inc (IRI). As a key member of our regulatory team, you will be responsible for reviewing product events, determining...

  • Regulatory Counsel Associate

    5 days ago

    Mountain View, California, United States Google Full time

    About the RoleWe are seeking an experienced Associate Regulatory Counsel to join our Global team, providing subject matter expertise and engaging with regulators, academics, and others to consider the role of competition law in our changing economy, the development of new technology, and passage of new laws and regulations.Key ResponsibilitiesInterpret laws...

  • Associate MDR Vigilance Specialist

    7 days ago

    Mounds View, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Assoc MDR/Vigilance SpecLocation: Mounds View/Hybrid 2 days Onsite (Wed & Thursday)Duration: 2 yearsJob Description:Responsibilities for this role include reviewing product events from a variety of sources to determine the complaint status and create the complaint record in the complaint handling system.This role is also responsible for determining...

  • Associate MDR/Vigilance Spec

    7 days ago

    Mounds View, United States Planet Pharma Full time

    $27 per hr 2 year extendable CONTRACTMounds View, MN - onsite 2 days per week REQUIRED:Bachelors degreeHealthcare experience Strong attention to detailStrong analytical skills (problem solving critical thinking)Strong writing skillsResponsibilities for this role include reviewing product events from a variety of sources to determine the complaint status and...

  • Associate MDR/Vigilance Specialist

    7 days ago

    Mounds View, United States Planet Pharma Full time

    GREAT OPPORTUNITY FOR FRESH GRADS TO GAIN EXPERIENCE WITH A GLOBAL INDUSTRY LEADING MEDICAL DEVICE COMPANY!Top Needs:1. Attention to detail2. Critical thinking skills3. Excellent written communication skillsResponsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program...

  • Plasma Center Paramedic

    5 months ago

    Mounds View, United States Biolife Plasma Services Full time

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Plasma Center Nurse

    5 months ago

    Mounds View, United States Biolife Plasma Services Full time

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Licensed Practical Nurse

    1 day ago

    Mounds View, United States BioLife Plasma Services Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my...

  • Vigilance Specialist

    7 days ago

    Mounds View, United States Redbock - an NES Fircroft company Full time

    A medical device company is seeking an Associate MDR/Vigilance Specialist for a 24 month contract. Candidates will be required to be onsite 2 days per week - Wed and Thurs - in Mounds View, MN. HM Top 3:Strong attention to detailStrong analytical skills (problem solving critical thinking)Strong writing skillsDescription:Associate MDR/Vigilance Specialists...

  • Regional Operations Associate Vice President

    3 weeks ago

    Mounds View, Minnesota, United States Premise Health Full time

    About the RoleWe are seeking an experienced Operations Associate Vice President to join our team in the Central Region, supporting clients in the Midwest. This role will oversee all operational initiatives within their book of business, planning and directing activities to align with overall region operations and maintain operational efficiency and service...

  • Clinical Research Specialist

    3 weeks ago

    Mounds View, United States Redbock - an NES Fircroft company Full time

    Clinical Research Specialist (24 month contract // On-site, team based in MN):HM's Top 3:Site Management experience (site or sponsor)Knowledge of/experience with CTMS/EDC/TMFExperience with Good Clinical Practice (GCP)Education Required: Bachelor Degree (prefer degree in engineering, life sciences, or related medical/scientific field.)Years’ Experience...

  • Clinical Research Specialist

    3 weeks ago

    Mounds View, United States Redbock - an NES Fircroft company Full time

    Clinical Research Specialist (24-month contract // Mounds View, MN):HM's Top 3:Site Management experience (site or sponsor)Knowledge of/experience with CTMS/EDC/TMFExperience with Good Clinical Practice (GCP)Education Required: Bachelor's degree (prefer degree in engineering, life sciences, or related medical/scientific field.)Years’ Experience Required:...

  • Clinical Research Specialist

    3 weeks ago

    Mounds View, United States Redbock - an NES Fircroft company Full time

    **CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**Clinical Research Specialist (24 month contract // Mounds View, MN):HM's Top 3:Site Management experience (site or sponsor)Knowledge of/experience with CTMS/EDC/TMFExperience with Good Clinical Practice (GCP)Description:In this exciting role as a Clinical...

  • Clinical Research Specialist

    3 weeks ago

    Mounds View, United States Redbock - an NES Fircroft company Full time

    Clinical Research Specialist (24 month contract // On-site, team based in MN):HM's Top 3:Site Management experience (site or sponsor)Knowledge of/experience with CTMS/EDC/TMFExperience with Good Clinical Practice (GCP)Education Required: Bachelor Degree (prefer degree in engineering, life sciences, or related medical/scientific field.)Years’ Experience...

  • Mental Health Counselor

    1 week ago

    mounds view, United States Rogers Behavioral Health Full time

    New Employee Retention Bonus *$2,000.00 retention bonus available! (In-training licensure) *$4,000.00 retention bonus available! (Fully licensed) (New Employee is defined as someone who has not been employed with Rogers for more than six months)The therapist leads the collaboration among an interdisciplinary team to develop, coordinate, and facilitate all...