Senior Regulatory Affairs Specialist - Medical Devices
Katalyst CRO
Katalyst CRO is seeking a Regulatory Affairs Senior Specialist to oversee global registrations and ensure regulatory compliance for medical devices, including Class I/II devices and software as a medical device. The role covers submissions, QMS alignment, and interpreting evolving standards across US, EU, and other regions. Ideal candidates hold a BS degree with 5–7 years in medical device regulatory affairs, strong ISO/FDA/EU MDR knowledge, Excel/database proficiency, and excellent #J-18808-Ljbffr Katalyst CRO
- The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device) The...Medical device
- ...under strict design controls and DOE practices. You will mentor engineers, drive DFMEA and PFMEA, manage schedules and budgets, and partner with customers, Sales and Manufacturing to deliver high-quality, scalable medical device components. #J-18808-Ljbffr ITW MedicalSeniorMedical device
- Responsibilities This role is responsible for Regulatory Affairs support of submissions and ongoing... ...positive relationships with device reviewers through oral and written communications... ...(e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical...Medical deviceWork experience placementWork at office
- ...Senior Validation Engineer Position Summary We are seeking a hands-on Senior Validation Engineer to lead the planning, development... ...within a regulated manufacturing environment such as medical device, pharmaceutical, or combination products. ~ Strong experience...SeniorMedical device
$126.94k
...simultaneously addressing the challenges of high-volume disposable medical component manufacturing that can include supply chain... ...injection molding high-volume manufacturing environment for medical device component production. Design for Six Sigma as demonstrated by a...SeniorMedical devicePermanent employmentWork at officeLocal area- ...process and train our internal team on regulatory requirements, data collection, reporting... ...Compliance, Finance, Sales, Marketing, Medical Affairs, Accounts Payable, Procurement, Travel... ...exclusions. Experience working in the medical device, pharmaceutical, biotechnology, or...Medical deviceTemporary workWork at officeFlexible hours
- ...An Exceptional Opportunity with an Established Surgical Medical Device Distributor. ABS Med Inc is seeking an experienced, driven medical device sales professional to manage our Chicagoland South Territory. This is a rare opportunity to step into one of the mostcovetedand...Medical deviceImmediate startFlexible hours
- Viltis is seeking an experienced Histotechnologist / Validation Specialist to support a medical device manufacturing organization in Richmond, Illinois. This on-site role will support histology product validation and Design History File remediation activities. The ideal...Medical deviceDay shift
- Katalyst CRO in the United States seeks a Regulatory Affairs professional to support submissions and ongoing compliance for medical device development and sustaining projects. You will coordinate US/EU filings, develop regulatory strategies, and guide teams through submissions...Medical device
$180k
Medical Device Sales - Paid Internship Looking for a lucrative career in the medical sales industry? Orthopaedic surgical sales could be for you! Average income more than $180,000 and an entry level average compensation of $95,057 Recession Resistant Work alongside surgeons...Medical deviceInternshipWork at officeWeekend workAfternoon shift- ...adjust focus.It would be a plus if you also possess previous experience in:Experience supporting facilities and equipment in a medical device, pharmaceutical, or regulated manufacturing environment.Proficiency with Microsoft Outlook, Microsoft Office Suite, and other business...Medical deviceHourly payWork at office
$40 - $50 per hour
Histotechnologist / Validation Specialist Location: Richmond, IL Schedule: Monday-Friday... .../ Validation Specialist to support a medical device manufacturing organization in Richmond... ...industry, supporting Quality, Regulatory, Clinical, Engineering, and Scientific...Medical deviceContract workWork at officeRelocation packageMonday to FridayDay shift- First Search Inc. seeks a Corporate Systems Quality Assurance Manager to lead company-wide quality management initiatives across manufacturing operations. You will oversee customer quality requirements, auditing programs, supplier quality, and corrective actions to ensure...Senior
- Scot Forge Company in Spring Grove, IL, is seeking an Organizational Development Manager to drive talent and performance initiatives. The role involves leading development strategies, implementing training programs, and fostering organizational effectiveness. The ideal ...Senior
$150k - $200k
...Senior Regional Safety Manager Pay from $150,000 to $200,000 per year Corporate Headquarters 12575 Uline Drive, Pleasant Prairie, WI 53158 Safety sets the standard at Uline. From the work environment to comprehensive training and procedures, we invest...Senior$140k
...Principal Systems Engineer-Medical Devices Location: McHenry, IL Hybrid Work Schedule: Three days a week on-site in McHenry and two... ...system requirements, performance expectations and applicable regulatory standards. Support risk management, design controls and technical...Medical deviceLocal areaHome office3 days per week- Charlie Mike Recruiting is seeking a Senior CAD Designer for our client in the commercial construction sector. The role focuses on creating... ...architects, engineers, and clients, and ensuring designs meet regulatory and project requirements. The ideal candidate has at least five...Senior
- ...About the job Senior CAD Designer Job Summary: We are seeking an experienced Senior CAD Designer specializing in commercial construction to join our dynamic team. The ideal candidate will have a minimum of five (5) years of experience in CAD design...Senior
- SMFCC is seeking a Senior Project Manager for restaurant construction to lead and oversee multiple projects from inception through closeout. The role emphasizes driving schedule and budget success while maintaining strong relationships with national brands. You will coordinate...SeniorFor subcontractor
$25 - $33 per hour
...are required to perform other related functions as assigned. Working Conditions The work conditions are in a climate controlled medical device assembly room. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions...Medical devicePart timeWork experience placementLocal areaImmediate startFlexible hoursShift workWeekend work- ...Senior Financial Analyst Corporate Headquarters 12575 Uline Drive, Pleasant Prairie, WI 53158 Are you a strategic finance professional who enjoys solving complex business challenges and influencing decision-making? As a Senior Financial Analyst, you'll partner...Senior
- Charlie Mike Recruiting is seeking an experienced Senior CAD Designer specializing in commercial construction to join a dynamic team in Illinois. The ideal candidate has 5+ years of CAD design for construction projects and strong knowledge of building codes and industry...Senior
- ...Medicoil have been trusted manufacturing partners delivering precision spring and wire form solutions to customers across the medical device, automotive, powersports, industrial, and commercial markets. Headquarters in Lake Geneva, Wisconsin, our family-owned and operated...Medical deviceFull timeWork at office
- Geneva Lake Manor in Lake Geneva, Wisconsin, is seeking an Activities Assistant to support the Director of Activities in planning, organizing, and leading recreational, social, and educational activities for residents. You will promote physical, emotional, social, and ...Senior
- ...Senior Staff Accountant Position Summary: As a Senior Staff Accountant, you'll play a key role in ensuring accurate financial... ...comprehensive package of benefits for eligible employees including Medical, Vision, Dental, Hearing, Life (Basic & AD&D), Disability (STD...SeniorMinimum wageWork at officeShift work
- Sustainable Staffing Inc. in McHenry, IL is seeking a Production Material Handler to support our medical device manufacturing operations on the first shift (Mon-Fri, 6:30 a.m. to 3:00 p.m.). This role involves replenishment, kanban-based order fulfillment, inventory control...Medical deviceDay shift
$90k - $110k
...Clinical Specialist – Gastroenterology / Endoscopy Greater Chicago | Field-Based/Remote | 50–75% Travel About Taurus Endoscopy Taurus Endoscopy is an early-stage medical device company developing next-generation tools for flexible endoscopy. We recently received...Medical deviceRemote workFlexible hoursNight shift- ...Senior Associate Attorney We are currently partnering with a distinguished boutique law firm, celebrated for its expert handling of estate planning, trust and estate administration, taxation, corporate matters, and real estate transactions for an elite clientele. In...Senior
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- ...CAD software in an academic, internship, or professional setting preferred. Experience in wire forming, spring manufacturing, medical device manufacturing, or another precision or regulated manufacturing environment preferred. Experience or coursework in Lean...Medical deviceInternshipWork at office
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