Senior Regulatory Affairs Specialist - Medical Devices (Hybrid)
$89.2k - $169.5kBoston Scientific
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 field and at least 4 years of experience in Regulatory Affairs, particularly with 510(k) submissions. The position requires strong analytical skills and effective communication. This hybrid role offers competitive compensation ranging from $89,200 to $169,500 depending on experience. #J-18808-Ljbffr
- ...Position : Senior Regulatory Affairs Specialist Location : Irvine, CA Duration : 10 Months Total... ...week : 40.00 1st Shift Client : Medical Devices Company Job Category : Clinical... ...or GC EAD or OPT or EAD or CPT Hybrid onsite 3 days JOB DESCRIPTION...SeniorMedical deviceContract workDay shift
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity... ...Specialist position (hybrid work mode) supporting our... ...growing active implantable device portfolio. This role will... ...Affairs experience in the medical industry Prior experience...SeniorMedical deviceWork at office
$92k - $148.35k
...Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California (Hybrid/Flex schedule, 3 days on-site). Purpose The Senior... ...equivalent field such as Quality, Medical, Clinical, or R&D.... ...Class II or Class III Medical Devices strongly preferred....SeniorMedical deviceContract workTemporary workLocal areaFlexible hours$92k - $130k
...Edwards Lifesciences Belgium is seeking a Regulatory Affairs professional to guide innovative technologies through regulatory environments. In this role, you'll represent the regulatory function on product development teams, ensuring compliance with both domestic and...SeniorMedical device$170k - $200k
...with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across... ...hesitate, come and join us! About this opportunity - Senior Principal Regulatory Affairs Specialist Description The Sr. Principal Regulatory...SeniorMedical device$92k - $130k
...patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex... ...and understanding of global regulations relevant to medical devices, Class II and/or Class III devicesFull knowledge and understanding...SeniorMedical device- ...Regulatory Affairs Representative Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...SeniorMedical device
- ...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 documentation...SeniorMedical device
- Alcon is seeking a Sr. Associate II, Regulatory Affairs Strategy in Lake Forest, California. This role involves supporting regulatory compliance... ...experience. Experience in the regulatory landscape of medical devices, strong technical writing skills, and commitment to...SeniorMedical device
- ...Job Description Our F500 Medical Device client has an exciting opportunity for an Electrical Engineer. Responsibilities and... ...Details: • Location: On-site (5 days per week) at Irvine, CA. Hybrid schedule can be considered after candidate is established within...Medical deviceContract work
- ...Job Description Our F500 Medical Device client has an exciting opportunity for a Senior Software Engineer. Job... ...maintaining software traceability and regulatory documentation. • Adapt and... ...extension • Work Set-Up: Hybrid in Arbor Lakes, MN • Start Date...SeniorMedical deviceContract workTemporary work
- ...BD Mexico is seeking a Senior Manager of Embedded Software Engineering... ...software development for medical devices. You'll manage and develop teams, ensure regulatory compliance, and collaborate with... ...standards. The position includes a hybrid work model with a minimum in-office...SeniorMedical deviceWork at office
- ...ONSITE ROLE. We don't want candidates asking/assuming this is hybrid. Candidates must be local to the Los Angeles / Orange County... ...expected to result in efficient and effective integration of medical device technologies to the portfolio. Successfully completing engineering...SeniorMedical deviceLocal area
$126.6k - $210.9k
...Senior Staff Regulatory Affairs Specialist Irvine, California As a Senior Staff Regulatory Affairs Specialist, you will influence global regulatory strategy... ...enable innovation and market access. Work Flexibility: Hybrid or Onsite Hybrid candidates must reside within...SeniorLocal area$67k - $90k
...Itlearn360 is looking for an Associate Clinical Research Specialist in Irvine, CA. This hybrid role involves ensuring clinical trials adhere to regulatory requirements and optimizing patient outcomes. Candidates should have a Bachelor's degree in Life Sciences or Nursing...Medical device$141.5k - $268.5k
...Associate Director, Regulatory Affairs US Advertising and Promotion AbbVie... ...today and address the medical challenges of tomorrow. We strive... ...to consult departmental senior concerning risks. In absence... ...Applicable pharmaceutical/medical devices/biologics experience,...Medical deviceTemporary workWork at officeImmediate startRemote workMonday to Friday- ...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...SeniorMedical device
$85k - $123k
Nihon Kohden Orange Med is seeking a Quality Assurance Engineer located in Santa Ana, California. This role focuses on overseeing compliance with FDA and ISO regulations, providing advanced quality engineering support, and conducting audits. Candidates should have a Bachelor...SeniorMedical device$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...SeniorMedical device- ...seeking an Associate Clinical Research Contracts Specialist for a full-time position in Irvine, CA. The hybrid role involves managing the contracting process... ...experience in clinical research, preferably in medical devices. Strong communication, organizational skills, and...Medical deviceFull timeWork at office
- ...collaborating with cross-functional teams. The ideal candidate will have a Bachelor's degree in Electrical Engineering or a related field and 3-5 years of experience in manufacturing engineering. Experience in the medical device industry is preferred. #J-18808-Ljbffr...SeniorMedical device
- ...lay the foundation for long-term growth. This role follows a hybrid work model requiring employees to be at a BSC office location... ...3 years of progressive product marketing roles in the medical device industry Willingness and ability to travel up to 40%, including...SeniorMedical deviceWork at officeRelocation package3 days per week
- ...A leading medical technology company in California is hiring a Senior Software Engineer for their Algorithm Development team. This role involves implementing advanced... ...for real-time signal processing in medical devices. Candidates should have extensive software development...SeniorMedical device
$74k - $104k
...Edwards Lifesciences is seeking a Regulatory Affairs professional in Irvine, CA, to support product development and regulatory submissions. You’ll ensure compliance with global regulations, prepare documentation packages, and represent regulatory functions in product...Medical device- ...Senior Design Assurance Engineer At Boston Scientific, we'll... ...and compliant with BSC and regulatory requirements. This Design Quality... .... This role follows a hybrid work model requiring employees... ...product development or related medical device / regulated industry...SeniorMedical deviceWork at officeLocal areaRemote workRelocation package3 days per week
- ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position... ...Ensuring rapid and timely approval of new medical devices and continued approved status of marketed medical devices...Medical deviceVisa sponsorshipRelocation package
- ...you ready to join us?This role is part of Alcon's Quality & Regulatory Affairs function, a critical organization responsible for ensuring... ...regulatory strategy execution with a focus on Retina medical devices within the Surgical franchise, partnering cross‑functionally...SeniorMedical deviceHourly payTemporary workLocal areaWorldwideRelocation packageFlexible hours
$74k - $104k
...Lifesciences in Irvine, California, is seeking a regulatory affairs professional to represent regulatory... ...the approval process for innovative medical technologies. The ideal candidate will... ...and knowledge of global medical device regulations. A competitive salary range...Medical device$120k - $155k
...A leading medical technology company in California is seeking an Embedded GUI Software Engineer to design and implement applications for patient monitoring devices. The ideal candidate will have strong skills in C++ software development, GUI design, and computer graphics...SeniorMedical device$145k - $205k
...telemetry, monitoring, and evaluation capabilities.Understanding of medical device infrastructure security, including securing connected devices... ..., Entra ID, OKTA, Auth0) including identity governance across hybrid and multi-cloud environments.Hand-on expertise in AWS cloud...SeniorMedical deviceWork experience placement
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist - Medical Devices (Hybrid). Be the first to apply!
- regulatory officer Irvine, CA
- compliance consultant Irvine, CA
- healthcare compliance officer Irvine, CA
- regulatory affairs consultant Irvine, CA
- senior compliance officer Irvine, CA
- senior regulatory affairs specialist Irvine, CA
- regulatory compliance specialist Irvine, CA
- risk and compliance analyst Irvine, CA
- aml compliance analyst Irvine, CA
- compliance officer Irvine, CA


