Current jobs related to Regulatory Systems Specialist II - South Jordan - Merit Medical Systems, Inc.

  • Trade Compliance Specialist II

    1 week ago

    Ladson, South Carolina, United States Elbit Systems of America Full time

    Job Title: Trade Compliance Specialist IIElbit Systems of America is seeking a highly skilled Trade Compliance Specialist II to support our export and import clearance processes. This role will ensure regulatory compliance of international cross-border transactions, working closely with our Integrated Solutions Division.Key Responsibilities:Provide trade...

  • Molding Operator II

    6 days ago

    South Jordan, Utah, United States Merit Medical Systems Full time

    About the RoleWe are seeking a skilled Molding Operator II to join our team at Merit Medical Systems. As a key member of our manufacturing team, you will be responsible for ensuring the quality of our cosmetic parts, dimensional charting, and paperwork completion.Key ResponsibilitiesPerform start-up dimensions and ensure compliance to drawings and...

  • Application Systems Analyst II

    3 weeks ago

    South Jordan, United States Merit Medical Full time

    Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. WORK SHIFT DAY (United States of America) SUMMARY OF...

  • Regulatory Affairs Specialist

    1 week ago

    South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Biologicals Labeling Specialist to join our team at Katalyst Healthcares & Life Sciences. As a key member of our regulatory team, you will be responsible for preparing new and revised label packaging for regulatory submissions to the USDA and maintaining regulatory documents to ensure site...

  • Production Assembly Specialist

    2 weeks ago

    South Jordan, Utah, United States Merit Medical Systems Full time

    About the RoleAt Merit Medical Systems, we are seeking a skilled Production Assembly Specialist to join our team. As a key member of our production team, you will be responsible for performing a variety of medical assembly and processing tasks, including technical assembly tasks and quality control inspections.Key ResponsibilitiesPerform medical assembly and...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    South San Francisco, California, United States R&D Partners Full time

    R&D Partners is looking for a Senior Regulatory Affairs Specialist III. Key Responsibilities: Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain submissions and product...

  • Regulatory Compliance Specialist

    2 weeks ago

    South San Francisco, California, United States Alumis Full time

    Job DescriptionOverviewAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.Job SummaryThe Safety Operations Specialist will play a critical role in ensuring timely reporting, processing, and submission of ICSRs from...

  • Supply Chain Procurement Specialist

    3 weeks ago

    South Jordan, Utah, United States Mytrex Inc Full time

    Supply Chain Procurement Specialist at Mytrex Inc.Location: South Jordan, UtahCompany: Mytrex Inc.About Us: Mytrex Inc. stands at the forefront of personal emergency response systems, committed to providing superior products while ensuring seamless supply chain management. We are in search of a proficient Supply Chain Procurement Specialist to oversee...

  • Regulatory Compliance Specialist

    6 days ago

    South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time

    Regulatory Compliance ManagerAt Katalyst Healthcares & Life Sciences, we are seeking a highly skilled Regulatory Compliance Manager to support our Sr. Director of Regulatory Process and Compliance in maintaining client compliance with regulatory requirements.Key Responsibilities:Assist in operational aspects of compliance activities, ensuring regulatory...

  • Engineer II, Information Security Assurance

    2 months ago

    South Jordan, United States CardWorks Full time

    Position Summary:The Identity and Access Management (IAM) Engineer II will work in the Merrick Bank and CardWorks security team. They will be involved in day-to-day activities regarding identity and access creation, risk-based access control, attribute-based access control, role-based access control, privileged access management, access modifications and...

  • Engineer II, Information Security Assurance

    2 months ago

    South Jordan, United States CardWorks Full time

    Position Summary:The Identity and Access Management (IAM) Engineer II will work in the Merrick Bank and CardWorks security team. They will be involved in day-to-day activities regarding identity and access creation, risk-based access control, attribute-based access control, role-based access control, privileged access management, access modifications and...

  • Proactive Systems Engineer

    1 month ago

    South Jordan, United States Executech Full time

    Job DescriptionJob DescriptionProactive Engineers provide remote and onsite expertise on a technical support team. They proactively serve as network administrators on a Service Delivery Team, partnering with the Service Delivery Manager and Senior Engineer in ensuring Executech’s products and services satisfy clients. They provide remote and onsite...

  • MRI Imaging Specialist

    3 weeks ago

    South Jordan, Utah, United States TotalMed Staffing Full time

    MRI Imaging SpecialistAbout the PositionAs an MRI Imaging Specialist, you will be responsible for operating advanced MRI machinery to capture detailed diagnostic images. Your role is vital in ensuring the comfort and safety of patients throughout the imaging process. Effective teamwork with fellow MRI professionals is essential to achieve the best imaging...

  • Data Analyst II, Acquisition Strategy Specialist

    2 weeks ago

    South Jordan, Utah, United States Merrick Bank Full time

    Job SummaryMerrick Bank is seeking a highly skilled Data Analyst II, Acquisition Strategy Specialist to join our Analytics and Data Science team. As a key member of our team, you will be responsible for developing and managing analytical processes to support loan acquisition strategies.Key ResponsibilitiesEvaluate and Improve Credit Card Product...

  • Systems Engineer II

    1 week ago

    South Chesterfield, United States Leading Solutions, LLC Full time

    Systems Engineer II – National Simulation Center, Fort Gregg-Adams, VA Specific tasks include: Conducts overall management coordination for all technical, networking, simulation, exercise design, and administrative support. Assists the Government in the design, development, delivery, and maintenance of simulation systems and...

  • Commercial HVAC Control Systems Specialist

    3 weeks ago

    South Boston, Virginia, United States Comfort Systems USA MidAtlantic Full time

    Commercial HVAC Control Systems SpecialistAre you a skilled HVAC control systems specialist seeking a rewarding career? Comfort Systems USA MidAtlantic is looking for a dedicated and knowledgeable HVAC professional to become part of our innovative team. We pride ourselves on being a military-friendly organization that values continuous learning and provides...

  • Molding Operator II

    2 weeks ago

    South Jordan, Utah, United States Merit Medical Systems Full time

    Job SummaryThis position is responsible for ensuring the quality of cosmetic parts, dimensional charting, and paperwork completion. The successful candidate will be responsible for submitting molded component lots to Quality Assurance for final audit approval.Key ResponsibilitiesPerform start-up dimensions as required.Package and weigh products, and make...

  • Molding Operator II

    1 week ago

    South Jordan, Utah, United States Merit Medical Systems Full time

    Job SummaryThis position is responsible for ensuring the quality of cosmetic parts, dimensional charting, and paperwork completion. The successful candidate will be responsible for submitting molded component lots to Quality Assurance for final audit approval.Key ResponsibilitiesPerform start-up dimensions as required.Package and weigh products, and make...

  • Molding Operator II

    1 week ago

    South Jordan, Utah, United States Merit Medical Systems Full time

    Job SummaryThis position is responsible for ensuring the quality and accuracy of cosmetic parts, dimensional charting, and paperwork completion. The successful candidate will be responsible for submitting molded component lots to Quality Assurance for final audit approval.Key ResponsibilitiesPerform start-up dimensions and ensure compliance to drawings and...

  • Water Systems Technician I, II, or III

    3 weeks ago

    West Jordan, Utah, United States City of West Jordan Full time

    Job OverviewOperator I - $20.63-$29.45Operator II - $22.79-$32.50Operator III - $24.56-$35.00Schedule: Four 10-hour shifts, 6:00am-4:30pm Monday- Thursday, every Friday offPosition SummaryThis role involves entry-level responsibilities in the management, upkeep, and repair of utility distribution or collection systems.SupervisionNo supervisory...

Regulatory Systems Specialist II

4 months ago

South Jordan, United States Merit Medical Systems, Inc. Full time

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

WORK SHIFT

DAY (United States of America)

SUMMARY OF DUTIES

This position is responsible for the creation, support, and improvement of global regulatory operations, systems, and processes.

ESSENTIAL FUNCTIONS PERFORMED

  • Develop, maintain, and update systems and databases per internal policies and procedures. Data validation of Regulatory Affairs Systems accurately and within established timelines.

  • Participate in data cleansing operations to facilitate appropriate and timely access to data for systems.

  • Develops, maintains, and improves various global regulatory processes and systems.

  • Works closely with global functions and departments to integrate processes and meet global regulatory needs.

  • Develops project plans as assigned. Tracks the staging of activities and milestones in regulatory work plans. Direct and manage project work processes.

  • Creates and provides training on regulatory systems across the organization as needed.

  • Identifies the need for new or revised procedures, user manuals, and data standards; ensures regulatory compliance and participates in development and implementation.

  • Provide updates to, and interact with, various levels of management, external agencies, and customers as requested.

  • Participate in and assist with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.

  • Remain current with global regulations, guidance documents, and standards and assist with global implementation, integration, and training when needed.

  • Perform other duties and tasks, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

  • Education and/or experience equivalent to a bachelor's degree in a technical field such as in the Computer Science, biological, physical, engineering, material science, regulatory, or related field disciplines.

  • Three years of experience in a related technical field such as computer science, data management, engineering, quality, regulatory, legal, etc.

  • Demonstrated knowledge in data entry and data management.

  • Demonstrated knowledge of Regulatory Affairs in related industries (e.g., medical device, pharmaceutical, or nutraceutical).

  • Demonstrated experience in generating and analyzing complex system queries and reports.

  • Demonstrated experience with project management, process development, and process improvement.

  • Experience in Regulatory Information Management (RIM) Systems a plus.

  • Intermediate technical writing skills.

  • Self-motivated, self-directing, strong attention to detail and time management skills.

  • Excellent interpersonal skills and the ability to communicate well - verbal and written.

  • Strong computer skills: RIM systems, spreadsheets, word processing, database, research, and other applicable software programs.

PREFERRED QUALIFICATIONS

  • Prefer PMI CAPM/PMP Certification

  • Experience in Medical Device Regulatory Affairs or Regulatory Operations is strongly preferred.

  • Experience with a RIM system is strongly preferred.

COMPETENCIES

  • Analytical, critical, and strategic thinking

  • Problem-solving

  • Propensity to learn

  • Interpersonal/communication/training skills

  • Technical writing

  • Project management

  • Process development

  • Process improvement

  • Computer, software, database skills

As an eligible Merit employee, you can expect the following:

* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

* Medical/Dental & Other Insurances (eligible the first of month after 30 days)

* Low Cost Onsite Medical Clinic

* Two (2) Onsite Cafeterias

* Employee Garden | Gardening Classes

* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

* 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.


EQUAL OPPORTUNITY EMPLOYER M/F/D/V. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled