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
$81.5k - $141.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...a passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team... ..., particularly supporting Class II and/or Class III products. Experience supporting commercially...Medical deviceFull timeFor contractorsShift work$90k - $180k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...and peripheral stents. Senior Regulatory Affairs Specialist This onsite opportunity is located in... ...evaluate regulatory history/background of class, disease/therapeutic/diagnostic...Medical deviceWork experience placementWorldwide- ...Field Action Quality Specialist We are seeking a Field Action Quality Specialist to... ...liaison between customers, quality teams, regulatory functions, and cross-functional... ...activities. Working knowledge of U.S. medical device regulations, including 21 CFR Part 820...Medical device
- 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
$25 per hour
Job Title: Compliance Specialist III Location: Sunnyvale, California Type: 6 month contract Compensation: $25/HOUR... ...: 40.0 Overview This role supports quality and regulatory compliance activities within a medical device manufacturing environment. The Compliance Specialist...Medical deviceContract workFor contractorsWork at officeLocal area$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 deviceRemote jobLocal areaFlexible hoursNight shift- ...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
- ...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
- ...Position Title: Regulatory Affairs Specialist Location: Sunnyvale, CA (Hybrid) Role Type: 6 Months of contract with possibility of extension... ...Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs...Medical deviceContract work
$125k - $145k
...and apply for the Senior Regulatory Affairs Specialist role at Hyperfine | AI‑Powered... ...strategy for the company’s devices and ensures compliance with... .... Strong knowledge of medical device labeling... ...FDA 510(k) clearances for Class II devices and interactions...Medical deviceWork experience placementWork at officeWork visaNight shiftWeekend work3 days per week- ...Regulatory Affairs Specialist (NMPA) This position will partner with the in-country RA team as well as the Product Localization Engineering... ...years RA experience is required. Minimum 1 year of NMPA medical device regulatory requirement China GB/YY standards, as well as...Medical deviceFor contractorsLocal areaFlexible hours
$34.58 - $38.91 per hour
...Patient Care Coordinator III We are seeking a go getter, deeply... ...activities such as device monitor scheduling, processing... ...and other health tracking for medication management. Insurance Authorizations... ...regular basis (through HealthStream classes, continuing education and...Medical deviceHourly pay$174.9k - $291.4k
...Regulatory Affairs Associate (Principal) - Medical Devices Imagine what you could do here. At Apple, excellent ideas have a way of becoming great products... ...knowledge of US regulations that affect Class I, II and III devices. ~ Experience with Software as a Medical...Medical deviceRelocation$90.9k - $122k
...quality standards across our operations. As a Quality Specialist III, you will support regulatory compliance and drive continuous improvement of... ...Experience in regulated industries (pharmaceutical, medical device, or biotech preferred) Experience with quality management...Medical deviceTemporary workWork at officeRelocation package$106k - $170.2k
Senior Regulatory Affairs Specialist Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional... ...executes regulatory strategies for new, modified, and marketed medical devices, prepares regulatory documentation for submissions to...Medical deviceWork at officeLocal areaImmediate startRemote workFlexible hours- ...than an open approach. Working with top medical professionals, they continue to... ...challenges worldwide. Position Senior Regulatory Affairs Specialist (Contract Basis) - Hybrid (3 days on‑... ...regulatory affairs experience in a medical device environment. Strong understanding of...Medical deviceContract workFor contractorsRemote workWorldwide2 days per week
- ...biomedical, or equivalent). • 5 to 6 years of medical device development experience, including... ..., or human factors engineering for Class III medical devices. • Proven ability to... ...Experience working closely with clinicians, clinical engineers, or medical affairs teams.Medical device
- ...decisions. In collaboration with Medical Office and Product Management... ...Product Management, Quality, Regulatory) to define product... ...plus 15+ years in the medical device industry. 10+ years in clinical... ...development and validation of Class III products Must be an expert on...Medical deviceFull timeWork at officeLocal areaWorldwideFlexible hoursShift work
$57.5k - $92.58k
...Manufacturing Technician III Fueled by innovation at the intersection of biology... ...schedules, 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 deviceCasual workLocal areaImmediate startAfternoon shiftEarly shift- ...opportunities.The Opportunity That Awaits You:The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured... ...Affairs.The ideal candidate would have had previous medical device experience and looking for potential for growth.What Your...Medical deviceWork at office
- ...Job Title Regulatory Affairs Specialist Location San Jose, CA Duration 12+ Months Client Medical Device Company Job Category Regulatory Affairs / Compliance Employment Type Contract on W2 (Need US Citizens Or GC Holders Only) No H1B’s Work Hours and Location 40hr/ week...Medical deviceContract workH1bLocal areaRemote work
- ...mechanical and electrical assembly skills. Responsibilities include equipment procurement, assembly testing, and documentation. A high school diploma or equivalent is required. Experience in the medical device field and ISO standards is preferred. #J-18808-Ljbffr eTeamMedical device
$200k - $250k
...paralysis operate digital devices using only their thoughts—... ...research into real‑world medical solutions. As a Precision... ...evidence strategies for a Class III neurotechnology device.... ...Partner closely with clinical, regulatory, and medical affairs teams to shape evidence...Medical deviceFull timeWork at officeRemote work- 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
$99k - $133k
...Overview VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing...Medical devicePermanent employmentInterim roleWork at officeRemote workRelocationVisa sponsorshipWork visa- Shockwave Medical is seeking a Quality Compliance Specialist II to join their team in Santa Clara, CA. This role focuses on ensuring compliance with Quality... ...Bachelor’s degree and 2+ years of experience in the medical device industry, including supporting FDA audits and...Medical device
$57 - $67 per hour
...Quality Compliance/Labeling Specialist Adecco Healthcare & Life... ...hiring for a notable global medical device organization recognized for... ...strong commitment to global regulatory compliance. This is a contract... ...closely with Regulatory Affairs, Quality, Engineering, and...Medical deviceHourly payWeekly payContract workTemporary workLocal area- ...Description About us: For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components...Medical deviceHourly pay
$26 - $40 per hour
...over three decades, Cirtec Medical has been a leading outsourcing... ...partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and... ...leading team performance and regulatory compliance. Be able to read...Medical deviceContract workTemporary workAll shiftsMonday to FridayShift work- ...decisions. In collaboration with Medical Office and Product Management... ...Product Management, Quality, Regulatory) to define product... ...plus. 15+ years in the medical device industry. 10+ years in clinical... ...development and validation of Class III products. Must be an expert...Medical deviceWork at officeLocal areaShift work
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