Regulatory & Quality Systems Lead (510(k), MDR/MDSAP)
The Matlen Silver Group, Inc.
The Matlen Silver Group, Inc. is looking for a Regulatory & Quality Systems Specialist based in Cary, IL, to ensure regulatory compliance for medical devices. The role involves working closely with cross-functional teams and requires direct experience with U.S. FDA regulations and quality systems. This position aims to enhance the overall quality management while maintaining compliance with both U.S. and international medical device regulations. A Bachelor's degree in a relevant field and skills in project management and technical writing are essential for this role. #J-18808-Ljbffr The Matlen Silver Group, Inc.
- Principal Specialist, Regulatory & Quality Management Systems {Cary, IL} (Heads up req) (BH-109535... ...of U.S. FDA regulations, EU MDR, and MDSAP, with hands‑on experience in 510(k) submissions and EU Class II... ...production and service controls. Lead or support internal and...QualityRegulatoryContract workWork at office
$66.66 per hour
...Title: Senior Information Systems Project Manager... ...Responsibilities Lead the team in the development... ...managers. Develop project Quality Plans and monitor... ...compliance with GxP and regulatory standards during project... ...participation in a 401(k) plan. System One is...QualityRegulatoryContract workWork experience placementLocal area- ...seeking an Associate Quality Manager, Stability to... ...U.S. and international regulatory requirements and supports... ...What you will do: Lead and continuously advance... ...policies, procedures, systems, and documentation to drive... ...Accounts (FSAs), 401(k) plan, Employee Stock Purchase...QualityRegulatoryTemporary workFlexible hours
$23 - $31 per hour
Position Summary As a Bakery Department Lead you will drive sales in your area and... ...Bakery department meets company and regulatory standards for quality, inventory, equipment usage, production... ...dental coverage. Financial benefits: 401(k), stock purchase, and company‑paid...QualityRegulatoryHourly payMinimum wageFull timeTemporary workPart timeImmediate start- ...The Manager, Quality Assurance Auditor is... ...for scheduling and leading domestic and international... ...Device Reports (MDR) as required to comply with all regulatory obligations. Create... ...offered include a 401(k) plan with company... ...based on the FDA's System Based Inspection...QualityRegulatoryPermanent employmentContract workWork visaFlexible hours3 days per week
- The Regulatory Affairs Coordinator provides operational and administrative... ...focus on assisting in 510(k) submissions, regulatory documentation... ...within document control systems Support product... ...Coordinate with internal teams (R&D, Quality, Marketing, Supply Chain) to...QualityRegulatoryInternshipWork at officeLocal area
- ...within the Northwestern Medicine system. We pride ourselves on... ...reimbursement and loan forgiveness to 401(k) matching and lifecycle... ...house registry team, proving high-quality care at our Outpatient... ...procedures, guidelines and all other regulatory and accreditation standards....QualityRegulatoryHourly pay16 hoursCasual workLocal areaRelocation packageFlexible hours
$107.44k - $161.16k
Commercial Process & Systems Lead page is loaded## Commercial Process & Systems Leadlocations... ...and nutrition, our teams develop high-quality taste solutions that inspire innovation... ...management, formula/recipe management, regulatory compliance, supplier collaboration, and...QualityRegulatoryLocal area$25 - $35 per hour
...CNC Lead (2nd Shift) Composed of Chromalox, Durex Industries, Vulcanic, and Thermocoax... ..., including industrial heaters and systems, heat tracing, and a range of component technologies... ..., testing and laboratory and quality assurance services. Durex serves businesses...QualityHourly payLocal areaShift workAfternoon shift$58 - $64 per hour
...Job Title: Senior Regulatory Affairs Specialist Location... ...Overview Join a leading medical device... ...someone with strong U.S. 510(k) and EU MDR Class IIa experience... ...regulatory requirements for quality, preclinical, and... ...distribution System One, and its subsidiaries...QualityRegulatoryContract workLocal area- OMRON Healthcare, Inc. is seeking a Regulatory Affairs Coordinator to provide operational support for regulatory submissions and compliance activities related to Class II medical devices. This entry to mid-level role focuses on ensuring accuracy in regulatory documentation...RegulatoryWork at office
$25 - $35 per hour
...Description Our client, a manufacturer of high-quality industrial heaters, temperature sensors,... ...controls, is seeking an experienced CNC Lead to join their team on 2nd Shift. Pay... ...long-term disability; AD&D insurance ~401(k) with employer match ~ Paid Vacation/...QualityTemporary workShift workAfternoon shift- ...assisting in the detailed review of internal quality systems. This Engineering role is responsible... ...of ISO, Government and other regulatory requirements. With direction, maintain... ...Insurance ~ Health Savings Account ~401(k) ~ Paid Time Off ~ Paid Holidays...QualityRegulatoryContract workWork at officeShift work
- ...concepts for problem solving. Leads basic root cause investigation... ...events. Understands and follows regulatory requirements in their area of... ...Information Management System (LIMS). Proficient in Microsoft... ...Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase...QualityRegulatoryTemporary workWork at officeFlexible hoursDay shift
- ...store in the absence of store management, including all required systems start-ups, required cash handling, and ensuring the floor and... ...additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the...RegulatoryWork experience placementSeasonal workLocal areaShift work
- ...Stryker is hiring a Senior Quality Engineer in Cary, IL... ...in and occasionally leads process improvement... ...internal and external audits (regulatory agencies, notified... ...Lead medium-scope quality system projects.... ...Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase...QualityRegulatoryTemporary workFlexible hours
$25 - $35 per hour
...CNC Lead Composed of Chromalox, Durex Industries, Vulcanic, and Thermocoax businesses... ..., including industrial heaters and systems, heat tracing, and a range of component technologies... ..., coordinating workflow, ensuring part quality, and maintaining safe and efficient...QualityHourly payLocal area- ...Overview Established in 1929, Heinen'sis a leading, family-owned grocery retailer known for its premium-quality products and outstanding customer service. Now in... ...proficiency in the HIPAA-compliant software system used for client engagement. Maintain well-stocked...QualityFull timeTemporary workPart timeWork at officeLocal areaFlexible hoursAfternoon shift
$112.9k - $188.1k
...and execution of test systems, fixtures, and methods... ...partner closely with R&D, Quality, Manufacturing,... ...Will Do You will: Lead the design, development... ...applying industry standards, regulatory expectations, or internal... ...Accounts (FSAs), 401(k) plan, Employee Stock Purchase...QualityRegulatoryTemporary workFor contractorsFlexible hours$63.38k - $89.47k
.... Overview The Quality Assurance Specialist is... ...responsible for supporting and leading all quality management... .... Quality System Compliance (ISO, CEIV,... ...and external audits. Regulatory Compliance: Ensure adherence... ..., Pet Insurance, 401(k) and Tuition...QualityRegulatoryWork experience placementLocal areaWorldwideFlexible hours$95k - $100k
...department, ensuring that HR systems, processes, compliance... ...excellence, regulatory compliance, and the overall... ...assignment to the position. 1. Leads the strategic... ...Ensures consistency and quality of HR service delivery... ...long-term disability, 401(k) and Roth 401(k) retirement...QualityRegulatoryFull timeTemporary workPart timeWork at officeFlexible hoursShift work$55k - $75k
...Maintain electronic filing system, clear folders at the COB each... ...Bonuses Perks & Benefits ~401(k) with Employer Match ~... ...religion, ethnicity and other qualities that makes us all different.... ...consulting services. This includes regulatory assets under management (AUM)...QualityRegulatoryWork from homeFlexible hours- ...with at least 1 year as a Press Lead or Supervisory position. ERP... ...(EFI Radius preferred), vision system and Novaflow ink mixing technology... ...for consistently producing quality printed material. The Press Lead... ...paid Sick and Vacation time, 401(k) with a company match, and paid...QualityWork experience placementShift workDay shift
$100k - $120k
...Opportunity My client is a leading manufacturer of high-... ...and consistent product quality has earned a trusted... ...elevate their quality systems and product standards.... ...sustainability metrics or regulatory compliance in plastics... ...insurance Vision insurance 401(k) Get notified about new...QualityRegulatoryFull timeShift work- ...Northwestern Medicine system. We pride ourselves on... ...loan forgiveness to 401(k) matching and lifecycle... ...Description The EVS Tech Lead position reflects the... ...and all other regulatory and accreditation standards... ...in maintaining a high-quality standard by keeping him...QualityRegulatoryPart timeWork experience placementLocal areaRelocation packageShift workAfternoon shift
$102.5k - $138.5k
...Accounting Manager is responsible for leading the accounting department to... ..., and compliance with all regulatory requirements. This role... ...multiple projects and produce high quality work under tight deadlines... ...of accounting and reporting systems (D365, Onestream, Excel) ~...QualityRegulatory- ...Quality Engineer Composed of Chromalox, Durex Industries, Vulcanic... ...industrial heaters and systems, heat tracing, and a range of... ...equipment qualification actions. Lead Quality System maintenance... ...meet customer and defined regulatory requirements. Leads internal...QualityRegulatoryWork at officeLocal area
- ...within the Northwestern Medicine system. We pride ourselves on... ...reimbursement and loan forgiveness to 401(k) matching and lifecycle... ...procedures, guidelines and all other regulatory and accreditation standards.... .... Documents tracking and quality issues on embedding log. Performs...QualityRegulatoryCasual workLocal areaRelocation packageNight shift
$70k - $90k
...Management (ACWM) Operations Manager leads process improvement and... ...is structured to deliver a high-quality client experience while ensuring operational accuracy, regulatory adherence, and internal process... ...Service Retirement Plan (401(k)) Clients Prepare...QualityRegulatoryFull timeWork experience placementWork at officeLocal area- ...Northwestern Medicine system. We pride ourselves on... ...loan forgiveness to 401(k) matching and lifecycle... ...guidelines and all other regulatory and accreditation... ...team. Coordinates and leads care conferences on patients... ...infection control and quality departments....QualityRegulatoryPart timeWork experience placementLocal areaRelocation packageFlexible hoursShift work
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