Senior Regulatory Affairs Specialist - Surgical Devices
$92k - $130kEdwards Lifesciences Corp.
Edwards Lifesciences in Irvine, California is looking for a Regulatory Affairs specialist to support product development and compliance with regulatory requirements. This role involves representing the regulatory function on development teams, preparing submissions for global regulatory agencies, and ensuring documentation meets regulatory standards. Candidates should have a Bachelor's degree and at least 5 years of experience in regulatory affairs. The position offers a competitive salary range of $92,000 to $130,000, depending on experience and qualifications. #J-18808-Ljbffr Edwards Lifesciences
$92k - $130k
Edwards Lifesciences Belgium is seeking a Regulatory Affairs professional based in Irvine, California. This role requires a Bachelor's Degree and a minimum of 5 years related experience. The successful candidate will be responsible for ensuring regulatory compliance throughout...Senior$89.2k - $169.5k
Boston Scientific is seeking a Senior Regulatory Affairs Specialist to join our team in Irvine, CA. The role involves supporting regulatory compliance and submissions for our active implantable device portfolio. Candidates should have a Bachelor's Degree in a scientific...Senior$92k - $130k
...Regulatory Affairs Specialist Make a meaningful difference to patients around the world. From design... ...lives. Dedicated to innovation, our Surgical business unit is focused on... ...global regulations relevant to medical devices, Class II and/or Class III devices...Senior$170k - $200k
...physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the... ..., come and join us! About this opportunity - Senior Principal Regulatory Affairs Specialist Description The Sr. Principal Regulatory Affairs...Senior- ...Position : Senior Regulatory Affairs Specialist Location : Irvine, CA Duration : 10 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices Company Job Category : Clinical Level of Experience : Mid-Level Employment Type : Contract on W...SeniorContract workDay shift
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of... ...mode) supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory...SeniorWork at officeLocal area3 days per week
$92k - $148.35k
...their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...for the best talent for a Senior Regulatory Affairs Specialist . This role will work a Hybrid/... ...with Class II or Class III Medical Devices strongly preferred. Experience...SeniorContract workTemporary workLocal areaImmediate startFlexible hours3 days per week$142k - $191k
MaxLinear is hiring a Principal Device Engineer in Irvine, California. This role involves R&D in semiconductor devices, emphasizing device characterization for RF/analog and digital applications. Candidates should possess a deep understanding of semiconductor device physics...Senior$92k - $148.35k
Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California (Hybrid/Flex schedule, 3 days on-site). Purpose The Senior... ...desired. Prior experience with Class II or Class III Medical Devices strongly preferred. Experience interacting directly...SeniorContract workTemporary workLocal areaFlexible hours- A staffing and recruiting company in California is urgently hiring a Regulatory Affairs Specialist. This role involves planning and implementing regulatory submissions for medical devices and requires in-depth knowledge of healthcare regulations. Candidates should have...Immediate start
- Pro-Dex, Inc. in Irvine, California seeks a Quality Assurance/Regulatory Affairs Specialist to support compliance and quality assurance activities related to medical device manufacturing. The role includes developing regulatory strategies, preparing reports for agency...Work at officeLocal area
- Masimo Wearables is hiring a Regulatory Affairs Specialist II in Irvine, California, responsible for obtaining regulatory clearances for medical devices. The role involves supporting domestic and international submissions, coordinating with regulatory teams, and ensuring...Flexible hours
- A leading medical devices company is seeking a Regulatory Affairs Specialist to join their team based in Irvine, CA. The candidate will be responsible for planning and implementing regulatory submissions while ensuring compliance with healthcare regulations. They will...
$124.7k - $205.8k
...Senior-Level Software Engineer BD is one of the largest global medical technology companies in the world. Advancing the world of... ...implementing advanced algorithms and software for cutting-edge medical devices, with a focus on real-time signal processing and system...SeniorWork at officeRemote work- ...Regulatory Affairs Representative Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of documentation...Senior
- ...Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance... ...lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...Senior
- ...LGM Pharma has an open position for a Senior Regulatory Affairs Specialist based in the Irvine, CA location. RESPONSIBILITIES: Planning: Oversee ANDA/NDA submission and approval process for regulatory. Collaborate in company Standard Operating Procedures...Senior
$83.9k - $120k
...registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in the US, Canada, and the EU.... .... Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice...Senior- ...registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in the US, Canada, and the EU. Analyzes... ...five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and...Senior
$126.6k - $210.9k
...Senior Staff Regulatory Affairs Specialist Irvine, California As a Senior Staff Regulatory Affairs Specialist , you will influence global regulatory strategy across the full product lifecycle while partnering closely with product development, quality, and clinical...SeniorTemporary workLocal areaFlexible hours$137k - $235.75k
Johnson & Johnson in Irvine, California is looking for a Programming Leader in the Medical Devices Sector. This role entails leading a team of SAS and R programmers responsible for statistical deliverables for clinical trials. The ideal candidate will have over 8 years...Senior$85k - $110k
...Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Irvine, CA facility. If you’re passionate about bringing the latest scientific discoveries to life...Senior- A medical device manufacturer in California seeks a Senior Engineer II for Quality Assurance. This role involves leading the design and development of medical devices, ensuring compliance with FDA and ISO standards, and supporting manufacturing transfers. The ideal candidate...Senior
$70 - $85 per hour
A leading medical device company based in South Orange County is seeking a Senior EMC Engineer for product certification and wireless electrical engineering. This hybrid role requires 4 days onsite per week. Ideal candidates will have a BS degree with at least 4 years of...Senior- ...technical resource firm in Irvine, California is seeking a Mid-Senior level Sr Process Engineer. You will provide engineering support... ...Engineering with relevant industry experience, particularly in medical devices. This contract role offers a hands-on opportunity to innovate...SeniorContract work
- A leading medical devices company seeks an NPD Program Manager to lead product development projects. The candidate should have at least 6 years of experience in managing complex product developments. Responsibilities include leading NPD teams, managing project budgets,...SeniorContract work
$115k - $145k
Beta Bionics, Inc. seeks a Senior Manufacturing Automation Engineer in Irvine, California. This pivotal role involves leading automation initiatives in a regulated medical device environment to enhance safety, quality, and production efficiency. Candidates should have at...Senior$124.7k - $205.8k
...seeking a Principal Electrical Engineer in Irvine, CA. This role involves supporting the development of electronic hardware for medical device systems. Candidates should have a strong background in electrical engineering, particularly in analog circuits, and experience in...Senior$100k - $123k
...standards organization in Irvine, CA, is seeking a Product Safety Engineer to manage the safety certification process for advanced medical devices. The role requires a Bachelor's degree in engineering (or related), extensive knowledge of safety standards, and strong project...Senior- A medical devices company is seeking a Senior Program Manager for New Product Development in Irvine, CA. The role entails leading NPD teams, overseeing project execution, and ensuring compliance with industry standards. Ideal candidates have at least 6 years of experience...Senior
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