Regulatory Affairs Specialists III
Job in
Milwaukee, Milwaukee County, Wisconsin, 53244, USA
Listing for:
Integrated Resources Inc.
Full Time
position
Listed on 2026-02-27
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly
USD
60000.00
80000.00
YEAR
Job Description & How to Apply Below
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description Participate as a team member on all assigned new product introductions as applicable.Communicate changes in existing products to applicable RA representatives for determination of the need for new/revised licenses or registrations.Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.Partner with applicable RA representatives for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of licenses.Identify any clinical data requirements for product licensing globally and ensure the requirements are documented in the compliance plan.Complete specific country testing and work with Region RA, and arrange for test devices and support as needed.Contribute to writing and editing technical documents.Research, analyze, integrate, and organize background information from diverse sources for regulatory submissions.Understand and apply regulatory requirements and their impacts for submissions.Ensure compliance with pre- and post-market product approval requirements.Support regulatory inspections as required.Perform a broad variety of tasks in support of product and process design as assigned by the departmental manager.Qualifications
Bachelor's Degree or a minimum of 4 years work experience.Minimum of 1 year experience working in a regulated industry.Ability to communicate effectively in English (both written and oral).Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.Quality Specific Goals
:Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.Complete all planned Quality & Compliance training within the defined deadlines.Identify and report any quality or compliance concerns and take immediate corrective action as required.Characteristics:Minimum of 3 years’ experience in a regulated industry is preferred.Advanced degree in scientific, technology or legal disciplines.Regulatory Affairs Certification (RAPS).Statistics education and or training.Ability to work independently in a fast-paced environment with little supervision.Ability to adapt to constant change and influence positive change effectively.Team-oriented and responsive to customer needs.Attention to detail and results-oriented.Ability to understand technical documentation and execute associated procedures.#J-18808-Ljbffr
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
