Regulatory Affairs Specialist - Medical Devices, Class III
Abbott Laboratories
A global healthcare leader is seeking a Regulatory Affairs Associate in Santa Clara, CA. This role involves managing regulatory submissions and approvals for medical devices, particularly Class III products. Candidates should have a Bachelor's or Master's degree in a relevant field and 5-8 years of experience in regulatory affairs, along with strong knowledge of FDA regulations. Benefits include medical, dental, vision plans, and a 401(k). #J-18808-Ljbffr Abbott
- ...Compliance Specialist III This role supports quality and regulatory compliance activities within a medical device manufacturing environment. The Compliance Specialist III ensures adherence to internal procedures and external standards, including FDA and global quality...Medical deviceWork at office
$115.5k - $156.4k
...Regulatory Affairs Representative Represents the Regulatory Affairs department in assigned... ...with state, federal, and international medical device regulations and overall regulatory... ...professional experience. Experience with Class III medical devices is preferred....Medical deviceLocal areaRemote workFlexible hoursNight shift- ...Job Title: Regulatory Affairs Associate Location: Santa Clara, CA Mode: 12 Months Contract / 100% Onsite Pay Range... ...reports Oversee manufacturing change approvals for Class III implantable medical devices Maintain compliance with FDA regulations and...Medical deviceWeekly payContract workTemporary workFlexible hours
$90k - $180k
...Senior Regulatory Affairs Specialist Abbott is a global healthcare leader that helps people live more... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...regulatory history/background of class, disease/ therapeutic/diagnostic context...Medical deviceWork experience placementWorldwide$190k - $210k
...About the job Principal Regulatory Affairs Specialist Principal Regulatory Affairs Specialist... ...of regulatory science for medical robotics. Your mission? To support... ...regulatory strategies for new and modified Class II and III devices and preparing and submitting...Medical devicePermanent employmentFull timeTemporary workLocal areaFlexible hours- Title: Regulatory Affairs Associate Location: Santa Clara, CA Duration: 12Months 100% Onsite Summary: We are looking for... ...manage regulatory submissions and approvals for medical devices, including high-risk (Class III) implantable products. The candidate will be responsible...Medical deviceTemporary workFlexible hours
- ...cost efficiency. The ideal candidate will collaborate with a team focused on continuous improvement and maintain compliance with medical device quality systems. If you have experience in lean manufacturing and an understanding of medical standards, we invite you to apply...Medical device
$50 - $55 per hour
...Global, Inc. is seeking a Quality Engineer III for a 12-month onsite contract in... ...involves providing compliance support to Regulatory Affairs, managing CAPAs and audit findings,... ...years of experience and knowledge of Medical Device regulations. The position offers a pay...Medical deviceHourly payContract work- ...Sr. Regulatory Affairs Specialist We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx... ...must have global regulatory experience working in IVD, Medical Devices or Pharmaceutical, with a history of successful regulatory...Medical device
- ...of Position: Serve as the primary regulatory representative on project and product core teams. The Regulatory Affairs Specialist works across the organization in supporting... ...years relevant experience working in a medical device company (can be in combination with a...Medical deviceLocal areaWorldwideFlexible hours
- Intuitive in Sunnyvale, California is seeking a Regulatory Affairs Specialist to serve as the primary regulatory representative on projects. The... ...Ideal candidates will have a minimum of 5 years in the medical device industry. This position supports innovation in robotic-...Medical device
- Quality Engineer III - Santa Clara, California (100% Onsite). 12‑Month contract.... ...role provides compliance support to the Regulatory Affairs organization, with opportunities to... ...and implement mitigations. Exposure to Medical Device US and CE regulations, quality systems...Medical deviceHourly payContract work
- ...cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted in accordance with company policies... ...years RA experience is required. Minimum 1 year of NMPA medical device regulatory requirement China GB/YY standards, as well as...Medical deviceFor contractorsLocal areaWorldwideFlexible hours
$145k - $167k
...Job Title : Senior Regulatory Affairs Specialist Location:Palo Alto, CA or... ...strategy for the company's devices and ensures compliance to Regulatory... .... Strong knowledge of medical device labeling... ...FDA 510(k) clearances for Class II devices and interactions...Medical deviceWork experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week$146.3k - $244.1k
...Senior International Quality and Regulatory Compliance Associate Apple is where individual... ...experience on international/OUS/ROW medical device projects in either a quality or... ...other global regulations that affect Class I, II and III devices ~ Strong knowledge of and...Medical deviceRelocation- ...Business Systems Analyst III SAP Procurement (SAP MM) Location: Sunnyvale, CA (Hybrid Role 2-3 days) Type: Contract Skillset... ...systems is nice to have Supporting users in a medical device company is desirable Possess a strong business and customer...Medical deviceContract work
- Research Associate III / Scientist I - Bioengineering & Microfluidic Assay Development... ...fabricate, and characterize microfluidic devices for integration with biological assays (e... ...Inc. is a privately held development-stage medical device company located in Sunnyvale, CA,...Medical deviceImmediate start
$57.5k - $92.58k
...Maintenance Technician III About MedTech Fueled by innovation at the intersection... ..., and maintaining compliance with medical device regulations. This role reports into the... ...to ensure adherence to workmanship and regulatory standards. Actively participate in quality...Medical deviceTemporary workCasual workLocal areaImmediate startMonday to FridayAfternoon shiftEarly shift- ...of a cortical surface array. This role requires at least 6 years of experience in the Class II or III medical device industry, with strong skills in program management and regulatory compliance. The candidate will coordinate efforts across engineering teams in California...Medical device
$20 - $25 per hour
...Overview: Pay Range: $20hr - $25hr Responsible for supporting regulatory compliance and quality management activities, including... ...timely resolution of issues. Should Have: Knowledge of medical device regulations and international quality standards....Medical device- ...Job Title: Compliance Specialist 3 Duration: 6 months Location: Sunnyvale... ...record retention based on company and regulatory standards. Essential Job... ...compliance (or combined experience) in the medical device or other regulated industry. Has...Medical device3 days per week
- ...and pyCells for iPDK. Understanding of device physics, Short Channel Effects, DIBL,... ...Description Quest Global delivers world-class end-to-end engineering solutions by leveraging... ...automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor...Medical deviceWork experience placement
- ...Field Clinical Specialist - VahatiCor Status: Exempt... ...Director of Clinical Affairs About the Company... ...is an early-stage medical device company developing breakthrough... ..., including Class III catheter-based systems... ...quality, safety, and regulatory compliance. About...Medical device
$110k - $130k
...Overview: Ampa is seeking a highly detail-oriented Regulatory Affairs Specialist to support our post-market regulatory activities and... ...Experience in quality systems is a strong plus, especially in a medical device startup environment where regulatory and quality work...Medical devicePermanent employmentH1bVisa sponsorship- A leading medical technology company is seeking a Complaints Specialist II in Santa Clara, CA. The role requires ensuring compliance with regulatory standards for medical devices. Responsibilities include initiating complaints, collaborating with teams, and reporting regulatory...Medical device
- Ampa Inc. in Palo Alto is seeking a Regulatory Affairs Specialist to ensure compliance in post-market activities for its neurostimulation systems... ...ideal candidate will have over 5 years of experience in medical device regulatory affairs, strong documentation skills, and...Medical device
- ...Regulatory Intelligence Specialist It started with a simple idea: what if surgery could be less invasive... ...years of experience in regulatory affairs and bachelor's degree in a relevant... ..., digital health, or complex medical devices. Familiarity with global regulatory...Medical deviceWork at officeLocal areaWorldwideFlexible hours
- ...Position: Regulatory Affairs Specialist Location: San Jose, CA Duration: 12+ Months Contract Total Hours/week: 40.00 1st Shift: Work hours: 8AM – 5PM Client: Medical Device Company Job Category: Regulatory Affairs / Compliance Level Of Experience: Seniority...Medical devicePermanent employmentContract workTemporary workH1bLocal areaRemote workShift workDay shift
- ...Function of Position The Compliance Specialist 3 - Supply Chain Audits executes audit... ...in conformance with applicable regulatory standards (21 CFR Part 820, ISO 13485,... ...Experience working in a regulated medical device or life sciences manufacturing environment...Medical deviceContract workLocal areaWorldwideFlexible hours
$75k - $95k
A global medical device company is seeking Regulatory Affairs personnel for various levels (Associate/Specialist/Senior Specialist) in Mountain View, CA. Responsibilities include analyzing Post Market Surveillance data, assessing Adverse Events, and managing product-related...Medical deviceFull time
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