Regulatory Affairs Specialists

Do you want to work for one of the largest “Healthcare” companies? They are currently looking for a “Regulatory Affairs Consultant” to support their facility in Waukesha, WI. If you’re interested and qualified, we urge you to apply!
 

Role Summary/Purpose:

This position provides regulatory subject matter guidance. Will work with a team of Regulatory Affairs professionals to ensure client establishes best practices in compliance with regulatory requirements..

Roles and Responsibilities:

This role will be involved with regulatory activities in the areas of premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc.

  1. Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets
  2. Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions,
  3. Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
  4. Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
  5. Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
  6. Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
  7. Contributes to writing and editing technical documents
  8. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
  9. Understands and applies regulatory requirements and their impacts for submissions
  10. Ensures compliance with pre- and post-market product approval requirements
  11. Supports regulatory inspections as required.
  12. Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations.

Required Skills and Experience:

  • Bachelor's Degree or a minimum of 4 years work experience.
  • Minimum of 1 year of experience working in a regulated industry
  • Ability to communicate effectively in English (both written and oral).
  • Ability to work effectively with a global cross-functional team.
  • Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Looking for Meaningful Work? We can help.

If you're a Regulatory Affairs consultant professional, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.

We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at recruit@ianmartin.com.

We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.

Data Analyst

Do you want to work for one of the largest “Healthcare” companies? They are currently looking for an “Data Analyst” to support their facility in Waukesha, WI.  If you’re interested and qualified, we urge you to apply!

Job Purpose:

The Data Analyst will be responsible for the supporting the delivery of the Supercharging Product Management centralized dashboard for the Healthcare Systems business.

Key responsibilities include (but are not limited to):

  • Planning, designing, or tracking performance metrics, is used by our leaders to make strategic business decisions. You will help organize, design, and communicate deliverable and will partner effectively with various global business teams.

Qualifications:

  • Bachelor’s Degree or minimum 5+ years related experience
  • 3 years of experience working in data management, business intelligence or equivalent
  • 2 or more years of experience working within a structure project management framework, PMP certification preferred.
  • Strong analytical skills including ability to create, manipulate and analyze large data sets
  • Expert proficiency in Microsoft Excel, moderate in PowerPoint.
  • Experience with analytics tools including Spotfire, Oracle Business Intelligence, SQL.

Looking for Meaningful Work? We can help.

If you're a Project Engineer professional, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.

We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at recruit@ianmartin.com.

We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.

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Administrative Assistant

Part time role flexible on scheduling and days of the week: Ideally, Mon-Fri at 4-5hrs/day or 4 days/week at 6hrs/day or 3 days/week at 8hrs/day. Any combination of that can work.

Role Overview / Summary :

The primary responsibility of this person will be to ensure the smooth and efficient administrative support to the Waukesha South Operations team. Responsibilities will be broad and changeable in nature ranging from coordinating payments to suppliers, coordinating tracking of radiation badges for employees, arranging conferences & meals, etc.

Responsibilities :

Support Client's Waukesha South Operations teams in general office administrative tasks

Process monthly corporate card and cash expenses including communications with suppliers as needed; and utilizing purchasing system for purchase orders, invoices & receipt tracking. Own process of radiation badge tracking for employees Provide calendar, meeting, and conference room management Coordinate communications within & outside of supported team Own email distribution lists & office cube layouts within supported team Keep organization charts up to date Handle highly confidential and sensitive information Coordinate travel arrangements Produce correspondence, presentations, meeting agendas, emails and any external mailings

Support teams by training or supporting others on technology, tools, or systems used in their everyday working practices.

Skills/Background

Experience with Microsoft products particularly Outlook, Excel & PowerPoint.

Engineering Technician

Do you want to work for one of the largest “Healthcare” companies? They are currently looking for an “Engineering Technician” to support their facility in Waukesha, WI for a 6 months contract duration. If you’re interested and qualified, we urge you to apply!

Position Summary:

Creation & detailed solder work on complex power electronics and controls circuits, set up and running of data acquisition equipment for tests, carrying out experiments, troubleshooting, and reporting/documenting results of tests and measures, lead compliance and quality activities, travel to customer sites for integration and service activities, and train other team members.

Duties include:

  • Performs troubleshooting of power electronics circuits (incl. 3 phase -delta and wye type), electrical control systems, printed circuit board designs, and plumbing or cooling systems. Designs and builds hardware that allows the team to conduct experiments or diagnostic tests and draw data-based conclusions.
  • Ability to measure, test, assemble or, repair where limited or no procedure exists.
  • Provides technical leadership by assisting others or in troubleshooting.
  • Assist other engineers through the test development, setup, and data collection process.
  • Constructs and assist in evaluating engineering models.

Qualifications:

  • Associates degree, or a High School diploma and 2 years technical experience
  • Advanced proficiency to logically troubleshoot at subsystem and system level, using identifiable problem-solving techniques and previous experience
  • Ability to draw accurate conclusions from test data, malfunctions, or deviations, and implement corrections to the existing design or process.

Looking for Meaningful Work? We can help.

If you're an Engineering Technician professional, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.

We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at recruit@ianmartin.com.

We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.

Field Cost Analyst

We are looking for an experienced Field Cost Analyst on behalf of one of the world's largest multinational oil and natural gas service companies.  Working on a long term contract, in the field, they will work closely with Project Controls and be responsible for gathering data and documentation and validate field costs for billing..

Responsibilities Include:

  • Deliverables include: Cost Report and Cost Variance Analysis, Cash Flow Report and Variance Analysis, Schedule Report and Schedule Variance Analysis, Project Change Management Procedure, Project Controls Plan, Monthly Progress Report Integrating Cost Control and Scheduling functions into one seamless team.
  •  Work with team to coordinate development of overall Project Execution Plan.
  • Performing quality control on all project control deliverables for completeness and accuracy.

Skills Required:

  • Bachelor's degree in engineering, or relevant technical discipline
  • 7+  years’ of relevant experience.