Regulatory Affairs Specialist II - Medical Devices
Abbott
Abbott in Alameda, CA is seeking a Regulatory Affairs Specialist II to perform specialized regulatory submissions for medical devices and guide product entries through FDA and international requirements. On-site role with cross-functional collaboration across engineering, QA, and marketing. You will evaluate regulatory guidelines, maintain up-to-date submission systems, and support the product release process to ensure compliant, timely market entry for Abbott's Lingo platform. #J-18808-Ljbffr Abbott
$81.5k - $141.3k
...of. Employees can qualify for free medical coverage in our Health Investment Plan... ...seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Alameda,... ...Preparation of regulatory submissions for devices to achieve departmental and...Medical deviceFor contractorsWorldwide$90k - $180k
...the future, anticipating changes in medical science and technology. Working... ...individual contributor, the Senior Regulatory Affairs Specialist will support product development... ...regulatory requirements for Class II software medical devices Assess the acceptability of documentation...Medical deviceShift work$100k - $200k
## Principle Regulatory Affairs Specialist - Diabetes Care (on-site)Applylocations: United States - California... ...and products in diagnostics, medical devices, nutritionals and branded generic... ...years’ experience working with Class II, Class III medical devices and/or biologics...Medical deviceWorldwideShift work$140k - $185k
...and most serious unmet medical needs. We work to... ...treatment options, creating devices aimed at restoring... ...Foundry. The Senior Regulatory Specialist will serve as the regulatory... ...and Regulatory Affairs team, where each team... ...Experience with Class II-III (implantable devices...Medical deviceFull timeLocal areaRemote workFlexible hours$96.4k - $128.5k
...are looking for a talented CQV Engineer II to join our team at our office located in... ...practices for C/Q/V services, and regulatory requirements. You may also perform standalone... ...supporting pharmaceutical, biotech, and medical device industries.Read, understand, and utilize...Medical deviceWork at officeNight shift$95k - $127k
...Description Job Description General Summary The Quality Engineer II develops and implements appropriate quality system elements to... ...quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination...Medical deviceTemporary workWork at officeLocal area- Mechanical Assembler or Operations Technician II Contract Integrated Resources, Inc is a... ...under microscope or other magnifying device. 7. Performs functional test using measuring... ...prints. 2. Manufacturing experience from a medical device or related industry 3.Microscope experience...Medical deviceContract work
$81.5k - $141.3k
...and products in diagnostics, medical devices, nutritionals and branded generic... ...Clinical Research Associate II Working at Abbott... ...department procedures and applicable regulatory requirements.... ...GCP, Clinical and Regulatory Affairs. Proficient with Microsoft...Medical deviceContract workInterim roleWork at officeWorldwideFlexible hoursShift work$30 - $41 per hour
General Summary The Equipment Technician II is responsible for the set up and maintenance of Penumbra’s manufacturing and test equipment... ...school diploma or GED with 3+ years of experience working in a medical device or in a manufacturing environment, or an equivalent combination...Medical deviceHourly payTemporary workWork at officeLocal areaRelocationShift work$100k - $200k
Abbott Laboratories is seeking a Principal International Regulatory Operations Specialist to join its Diabetes Care Division. The role involves... ...discipline, experience with regulatory submissions for medical devices or pharmaceuticals, and excellent communication skills....Medical device$95k - $127k
...General Summary The Quality Engineer II develops and implements appropriate quality system elements to ensure the high-quality... ...quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of...Medical deviceWork at office$160k - $190k
Principal Global Regulatory Affairs Specialist Hayward, CA - Onsite Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine... ...in general surgery, and cardiac surgery and dermatology medical devices in targeted global markets. She/he provides leadership in...Medical deviceWork at officeLocal areaRelocationFlexible hoursNight shift- ...a Senior Biomedical Engineer for a top medical-device client developing innovative treatments... ...engineering testing, supplier management, regulatory documentation, and production-line development... ...leadership, and bringing complex Class II or Class III products to market....Medical device
- ...Quality Agreements by developing criteria, ensuring alignment with regulatory standards, and collaborating with suppliers to address... ...requirements and trends related to quality compliance in the medical device industry. Responsible for timely communication with suppliers...Medical device
$30 - $41 per hour
...General Summary The Equipment Technician II is responsible for the set up and maintenance of Penumbra’s manufacturing and... ...school diploma or GED with 3+ years of experience working in a medical device or in a manufacturing environment, or an equivalent combination...Medical deviceHourly payWork at officeRelocationShift work$65 per hour
...opportunity reach out to our Talent Acquisition Specialist Diresh Krishnan at email address... ...Logistics R&D Operations and Regulatory. Ensure the cross-functional team is... ...Experience/Background: Experience in medical devices and/or pharmaceuticals is a plus. Proven...Medical deviceHourly payPermanent employmentContract workTemporary workWork experience placementWork at officeShift work$100k - $200k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...**This **Principal International Regulatory Operations Specialist** will work on-site at our Alameda,... ...(such as RAC from the Regulatory Affairs Professionals Society.)* 2-3 years...Medical deviceWorldwide- ...adaptive algorithms, and assistive devices to translate neural intent... ...for a Firmware Engineer II who is passionate about developing... ...testing embedded software for medical devices. You'll contribute to... ...results to support development and regulatory activities. Investigate...Medical deviceFull timeWork at office
- Abbott is seeking a Senior Regulatory Affairs Specialist to support Lingo product development and regulatory activities for US commercialization... ..., and rigorous documentation, with a focus on Class II software medical devices and 510(k)/PMA pathways. On-site opportunity in...Medical device
$72k - $99k
...Maintenance Technician II This is where your work makes a difference. At Baxter, we believe every personregardless of who... ...school diploma or GED, Technical Associates degree preferred. Medical device or pharmaceutical regulated industry experience preferred. Compensation...Medical deviceTemporary workWork visaFlexible hours- ...Quality Engineer to lead Quality Engineering for new life-saving medical devices. You will design controls, qualify products, and ensure... ...inspections and audits, and mentor teams in quality systems while advancing innovative therapies. #J-18808-Ljbffr Regulatory ToolkitMedical device
- California State University - East Bay seeks a Credential Analyst II to maintain oversight of candidate files, interpret credential requirements, and guide students through California certification processes. The role emphasizes accuracy, confidentiality, and collaboration...
- ...General Summary As an R&D Engineer at Penumbra, you get to be hands-on, prototyping the next generation of medical devices! We are looking for someone who is excited to roll up their sleeves and relentlessly iterate on new ideas for electro-mechanical systems. You will...Medical deviceWorldwide
- Penumbra, Inc., headquartered in Alameda, California, is seeking an Equipment Technician II to set up and maintain manufacturing and test equipment and document activities per the company’s Quality System. You will perform preventative and on-demand maintenance, assist...Medical device
- ...product development team, design and qualify new life-saving devices, implement design control, and ensure QMS compliance. You will... ...across functions to maintain high standards, focusing on accuracy, problem solving, and regulatory readiness. #J-18808-Ljbffr PenumbraMedical device
$148.7k - $297.3k
...StatesEmployment type: full timeCategory: Regulatory AffairsIndustry: HealthcarePosted: 2026... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...This Associate Director, Regulatory Affairs will work on-site at our Alameda, CA location...Medical deviceWorldwide$150k - $200k
Full Spectrum in Emeryville, CA, is seeking a Director of Business Development to drive new business within the Medical Device and Life Sciences industries. This client-facing role demands expertise in sales and a strong networking capability, vital for meeting the company...Medical device- The City of San Leandro is seeking a Hazardous Materials Specialist I/II to perform monitoring, inspections, and compliance work under the CUPA program, covering APSA, CalARP, and underground storage tank oversight. This entry- to journey-level position progresses with...
- ...Job Description Job Description Job Title: Sr. Regulatory Specialist Duration: 6 Months Contract (Possibility of Extension... ...Description: Must have 7 years of experience in Medical Device Regulatory Affairs. Highly experienced in regulatory change assessments...Medical deviceContract workShift work
$37 - $43 per hour
...career, join us as we pioneer progress in the biotechnology and medical device industries. Workplace: Emeryville, CA. Position Title:... ...and provide technical guidance to junior QC analysts. Support regulatory inspections, client audits, and other quality engagements. Identify...Medical deviceContract work
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