Head of QA/RA - US Medical Devices (510(k) Expert)
$150k - $170kCSG Talent
A leading medical device company is seeking a Quality and Regulatory Affairs Lead based in Southern California. The successful candidate will oversee all USA QA and regulatory functions, ensuring compliance with FDA regulations for Class II medical devices. A proven track record in Quality Assurance and Regulatory Affairs is essential. This is a full-time role with a competitive salary range of $150,000 to $170,000 plus bonuses and requires flexibility for office presentations. #J-18808-Ljbffr
$150k - $170k
...Critical Care equipment/devices & Hospital... ...implementation of entire USA QA/RA strategy The... ...ensure timely initial 510(k) clearance and... ...Oversees all aspects of US based Quality... ...Assurance Industries Medical Equipment Manufacturing... ...in a new way. Experts add insights directly...Medical deviceFull timeWork at officeImmediate startRemote work$90k - $150k
...100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as... ...background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and...Medical deviceFull time- ...collaborative environment. Our team of experts works on cutting-edge projects... ..., cosmetics, food, and medical devices industries. Job Title: Associate Director, Global RA Labeling Lead Job Type:... ...labeling requirements, particularly US and EU regulations, and the...Medical devicePermanent employmentRemote work
$108.03k - $140k
...documentation. They also provide QA document review, impact... ...process.Applies knowledge of medical device regulatory requirements to identify... ...paid holidays and up to 5% 401(K) match and tuition... ...years, and you can grow with us! Third Party Agency and Recruiter...Medical device$184.4k - $276.65k
...various teams, including Marketing, Medical Affairs, Sales, and Managed... ...delivery payors both in US and Global markets.Build a continuing... ...PODD) is an innovative medical device company dedicated to simplifying... ...with global offices in the U.K., France, Germany, Netherlands,...Medical deviceFull timeWork at officeRemote work$136.4k - $204.58k
...Insulet. As the Senior Manager, US Field Marketing Tools &... ...closely with Sales, Marketing, Medical Affairs, Training, and CRM teams... ...enablement within the medical device or pharmaceutical industry. This... ...dental, and vision insurance • 401(k) with company match • Paid time...Medical deviceFull timeWork experience placementWork at officeLocal area- ...the largest global medical technology companies... ...passion of all of us—from design and engineering... ...modified medical devices in the United... ...Premarket Notification 510(k) submissions in a... ....Represent RA in product life cycle... ...&D, Manufacturing, QA, Medical and other...Medical deviceWork at officeRemote workShift work
$20 - $25 per hour
...shift in San Diego, CA. This 12-month contract on W2 requires US citizenship or GC holders and offers a 10:00 pm to 5:00 am shift... ..., adherence to SOPs and quality standards, and final disposition of nonconforming items in a medical devices environment. #J-18808-Ljbffr...Medical deviceHourly payContract workShift workNight shift- ...before release. You will collaborate with developers, PMs, and QA peers in a fast-paced, regulated environment, applying manual... ...in Jira, and helping mature QA processes. Experience in medical devices or IVD is preferred; BS/MS in CS or Engineering required; knowledge...Medical device
- ...Top 3 Skills: - Hands-on experience in Depot Management/Configuration Center operations. - Strong knowledge of End-User Device Lifecycle Management (laptops, desktops, AV, smart devices). - Working experience with Microsoft ecosystem and device management tools...Medical deviceWork experience placementWork at office
$180k - $220k
...ASIC Technical Lead Full Time San Diego, CA, US 2 days ago Requisition ID: 1046 Salary Range: $1... ...those gaps. Nice to have: experience in a regulated medical device environment (design controls, DHF, 510(k)/PMA) or with implantable-class electronics. Base...Medical deviceFull time$129.6k - $207.4k
...the largest global medical technology companies... ...passion of all of us—from design and engineering... ...modified medical devices in the United... ...Premarket Notification 510(k) submissions in a... .... Represent RA in product life cycle... ...&D, Manufacturing, QA, Medical and other...Medical deviceHourly payWork at officeRemote workFlexible hoursShift work$140k - $145k
...Arrangement: In Office Quality Manager, Medical Device, San Diego, CA. $140,000-$145,000Are you... ...Experience overseeing both Quality Assurance (QA) and Quality Control (QC) functions.... ...benefits package, including employer 401(k) contributions and matching that can total...Medical deviceWork at office- ...Associate Vice President, US Philanthropy About the Company Non-profit org providing surgeries for children with facial... ...Nonprofits Cosmetic and Plastic Fundraising Health Medical Devices & Equipment Medicine Nonprofits Organizations Surgery...Medical device
- ...Associate Vice President, US Corporate Partnerships About the Company Non-profit org providing surgeries for children with... ...Cosmetic and Plastic Fundraising Health Medical Devices & Equipment Medicine Nonprofits Organizations Surgery...Medical device
$140k - $150k
...mission forward. As a global medical technology leader for nearly 1... ...standards, including compliance with US FDA regulations governing the... ...and sale of medical devices domestically and internationally... ...including Traditional and Special 510(k)s, Letters to File, Pre-Subs,...Medical deviceWork at officeFlexible hours$99.96k - $145k
...Capability (TSTC) Subject Matter Expert (SME) to serve as the primary... ...benefits such as best-in-class medical, dental and vision plan choices... ...programs; Savings Plan Options (401(k)); financial planning tools,... ...@hii-co.com and let us know the nature of your request...Full timeWork experience placementLocal areaWorldwide$90k - $100k
...are making a difference in medical care by offering medical devices for diagnosing a variety of... ...patient directly. Come join us in developing the latest... ...meet the timetable; Assist RA department for 510K... ...insurance, along with a 401(k) plan, employee assistance...Medical device$91.7k - $137.53k
...initiatives to ensure regulatory approval of medical devices in both domestic and international... ...changes for regulatory impact, including:• US labels in English• Review of... ...with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian...Medical deviceFull timeWork at office$230k - $250k
...position reports to the Vice President, US Quality Operations and is a key member of... ...experience with in-vitro diagnostics or medical device industry, with direct accountability for... ...medical/dental/vision insurance and 401(k) to eligible employees.Danaher Corporation...Medical deviceLocal area$98.04k - $227.82k
...Our Total Rewards package includes a variety of medical and dental plans, vision coverage, disability and life insurance, 401(k) plans, and a robust suite of personal well-... ...benefits can be found towards the bottom of our KPMG US Careers site at Benefits & How We Work.Follow...Local area$240k - $280k
...Head of Quality & Regulatory Affairs - Autoimmunity Country... ...Technology Centers are located in the US and Europe, and our workforce... ...of QC product testing and QA product release dispositions.... ...leadership experience, within the medical device industry required....Medical deviceWork experience placementWorldwideShift work$180k - $220k
...document that is the single source of truth between us and the design partner. Design & architecture reviews... ...those gaps. Nice to have: experience in a regulated medical device environment (design controls, DHF, 510(k)/PMA) or with implantable‑class electronics. Pay...Medical deviceFull timeInternshipFlexible hours$20 - $25 per hour
...Level Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) M-F; 9am-5:30pm Position : QA Inspector I Location : San Diego, CA... ...00 pay rate-$20-25/hr 1st Shift Client : Medical Devices Company Job Category : Quality Level of Experience...Medical deviceContract workWork at officeLocal areaDay shift$198k - $328k
..., is seeking a Chief AI Subject Matter Expert (SME) to be part of our Integrated Warfare... ...solutions to ensure the highest impact to the US Navy. Clearance & Location Requirements... ...~ Competitive PTO ~ Paid holidays ~401(k) with immediate vesting and matching ~9/8...Full timeWork at officeImmediate start$23 - $25 per hour
...equivalent, and authorization to work in the US Preferred Experience Experience reading... ...quality procedures Background in optics, medical device, or semiconductor manufacturing... ...Savings Account (HSA) Life insurance 401(k) matching PTO, sick time, and paid company...Medical deviceHourly payPermanent employmentFull timeLocal areaMonday to FridayShift workDay shift$117.3k - $195.5k
...and lead dashboard design Collaborate with Medical Impact and Outcomes team lead to ensure... ...Lake Forest, IL; La Jolla, CA; Boulder, CO; US - remote; Montreal, Canada Eligible for Relocation... ...s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions...Remote workRelocation packageFlexible hours- ...delivering against a quota), preferably in the neuromodulation space, medical device, or related industry - strong business-to-business selling... ...we are looking for?Apply now! Hit the “Apply” button to send us your resume and cover letter. Bioventus is committed to fostering...Medical deviceFull time
$70 - $75 per hour
...benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).... .... \n ~ DFSS (Design for Six Sigma)\n ~ Medical Device / Regulated Product Experience – Experience developing medical...Medical deviceContract workLocal areaImmediate start$110k - $177k
...Signal Processing Ultrasound Engineer - Medical Device (San Diego, CA)Job DescriptionDigital Signal... ...related field. PhD desired.You are an expert in MATLAB.You must be able to... ...circumstances of each case. Additional Information:US work authorization is a precondition of...Medical deviceImmediate startWork visaRelocation package
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