International Regulatory Affairs Specialist (Medical Devices)
Edwards Lifesciences Gruppe
Edwards Lifesciences Gruppe in Irvine, California, seeks a Regulatory Affairs professional to lead regulatory guidance for innovative technologies. Responsibilities include preparing documentation for global regulatory submissions and ensuring compliance with requirements. The ideal candidate has a Bachelor's Degree and at least 3 years of regulatory experience. The position offers competitive salaries, performance incentives, and a supportive benefits program for employees and families. #J-18808-Ljbffr
$92k - $130k
...Edwards Lifesciences Belgium is seeking a Regulatory Affairs professional to guide innovative technologies through regulatory environments... ...teams, ensuring compliance with both domestic and international regulations. The ideal candidate will have a Bachelor's degree...InternationalMedical device- ...This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems...InternationalMedical deviceWork at office
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the... ...growing active implantable device portfolio. This role will... ...requires strong US, EU, and international regulatory experience that... ...Affairs experience in the medical industry Prior experience...InternationalMedical deviceWork at office
$92k - $130k
...world. From design to production, our Regulatory Affairs teams help guide our innovative... ...technologies through complex domestic and international regulatory environments. Working in... ...of global regulations relevant to medical devices, Class II and/or Class III devicesFull...InternationalMedical device$170k - $200k
...and institutions to develop elegant medical devices. Our products are being used by... ...this opportunity - Senior Principal Regulatory Affairs Specialist Description The Sr.... ...and documentation for the US and internationally. # Support product maintenance for...InternationalMedical device$60k - $65k
...Supports tasks related to Regulatory and Compliance... ...local, state, federal, international regulations and customer... ...pertaining to medical device and medical device manufacturing... ...or regulatory affairs. One or more years of... ...Assurance/Regulatory Affairs Specialist MENTAL, PHYSICAL...InternationalMedical deviceApprenticeshipLocal area$74k - $104k
...design to production, our Regulatory Affairs teams help guide our innovative... ...complex domestic and international regulatory environments. Working... ...patient care with devices supported by clinical evidence... ...global regulations relevant to medical devices, Class II and/or Class...InternationalMedical device$80.6k - $133k
...Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-... ...proactive Regulatory Affairs Specialist to support global product... ...regulatory and product data across internal systems, enabling compliant... ...of EU MDR/MDD, FDA medical device regulations, and other international...InternationalMedical deviceFlexible hours$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$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$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...Medical device- ...Position : 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 W2 (Need...Medical deviceContract workDay shift
- ...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...Medical 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...Medical device
- ...Responsibilities Support US and EU regulatory submissions, ensuring protection... ...cross-functionally with internal teams Perform additional duties... ...-on experience in Regulatory Affairs ~ Experience supporting medical devices (Class II and/or Class III) ~ Exposure...Medical device
$90k - $140k
...Regulatory Strategy Lead Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic...Medical device- ...Job Summary The Regulatory Affairs Specialist (FDA, DEA)will ensure BaRupOn's pharmacy, manufacturing... ...related to pharmaceuticals, medical devices, and controlled substances. Key... ...and labeling requirements Support internal audits, site inspections, and responses...Medical device
- ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or... ...rapid and timely approval of new medical devices and continued approved status of marketed... ...requirements and adherence to internal policies and processes. In a...Medical deviceVisa sponsorshipRelocation package
- ...Position : Production Operator (Must Have Medical Device Assembly Exp) Location : Irvine, CA Duration : 3 Months Contract Total... ...), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization). Effectively works in a...InternationalMedical deviceContract workFlexible hours
$92k - $148.35k
...Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California... ...of contract resources or interns. Qualifications Minimum of... ...field such as Quality, Medical, Clinical, or R&D. Demonstrated... ...II or Class III Medical Devices strongly preferred. Experience...Medical deviceContract workTemporary workLocal areaFlexible hours- ...engineering role Experience leading complex medical device development from concept to market Strong knowledge of regulatory requirements and quality standards in the... ...Availability for up to 25% domestic and international travel Working Place: Irvine, California...InternationalMedical device
$70k - $90k
...Regulatory Affairs Specialist Job Category: Regulatory Affairs Requisition Number: REGUL001270 Posted: April 22, 2026 Full-Time Hybrid... ...and other Regulatory Agencies as required, including international registration documents for cosmetic and drug products....InternationalFull timeWork experience placementWork at officeRemote workShift work- ...activities within a regulated medical device environment. The ideal... ...product development experience, regulatory knowledge, and the ability to... ...activities across internal teams, suppliers, and stakeholders... ...with R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain...InternationalMedical device
$120k - $130k
...collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world... ...plan and run projects is highly desired Able to travel internationally, especially to Europe Skills: Ability to prepare...InternationalMedical deviceWork at office$126.6k - $210.9k
...Senior Staff Regulatory Affairs Specialist Irvine, California As a Senior Staff Regulatory Affairs Specialist, you will influence global regulatory... ...with regulatory authorities in the United States or international markets. $126,600 - $210,900 USD Annual #J-18808-Ljbffr...InternationalLocal area- ...Well-established and growing international manufacturing/distribution organization is seeking a hands‑on Accounting Manager to join their... ...practices Experience within manufacturing, distribution, medical device, consumer products, or related operational environments preferred...InternationalMedical device
- ...A cutting-edge medical device company with a wide and growing range of highly innovative healthcare products is currently seeking a Product... ...input to training material development and participate in internal/external training activities * Liason with Upstream Product...InternationalMedical deviceWork at office
- ...and maintaining a clean, organized work area Industry: • Medical Device Manufacturing Estimated Start Date: • 6/8/2026... ...Department of Industrial Relations' website here . Rose International is an Equal Opportunity Employer. All qualified applicants will...InternationalMedical deviceCasual work
- ...This position is responsible for the production of high quality medical devices within a cleanroom environment 1.Working under close... ...solutions 4.Maintain a positive attitude when interacting with internal customers and external customers 5.Follow safety guidelines...InternationalMedical deviceExtra incomeFull timeH1bLocal areaVisa sponsorshipWork visaAfternoon shift
- ...Sr. Automation Test Engineer (Ranorex/Medical divices) Job Description... ...experience preferably with complex medical devices. • Working knowledge and hands-on experience... ...network. • Ability to travel up to 10%, international and domestic, is required. Job...InternationalMedical deviceFlexible hours
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