Global Regulatory Affairs Specialist - Surgical Devices
$74k - $104kEdwards Lifesciences
Edwards Lifesciences in Irvine, California, is seeking a regulatory affairs professional to represent regulatory functions and oversee documentation for global submissions. This role is vital in ensuring compliance and facilitating the approval process for innovative medical technologies. The ideal candidate will possess a Bachelor's degree, with at least 3 years of relevant experience and knowledge of global medical device regulations. A competitive salary range of $74,000 to $104,000 is offered based on experience. #J-18808-Ljbffr
$92k - $130k
...From design to production, our Regulatory Affairs teams help guide our... ...Dedicated to innovation, our Surgical business unit is focused on... ...packages for submission to global regulatory agenciesAssist with... ...regulations relevant to medical devices, Class II and/or Class III devicesFull...Suggested$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...Suggested$74k - $104k
...Lifesciences Belgium in Irvine, California is looking for a Regulatory Affairs professional to support product development and regulatory submissions... ...function on various teams and prepare documentation for global regulatory agencies. Requirements include a Bachelor's Degree...Suggested- ...California is seeking a Senior Associate II in Regulatory Affairs Strategy to support compliance for their Surgical portfolio. You will coordinate submissions and ensure... ...regulatory strategies for Retina medical devices. Ideal candidates have regulatory experience in...Suggested
$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...Suggested- ...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...Visa sponsorshipRelocation package
$74k - $104k
...From design to production, our Regulatory Affairs teams help guide our... ...Dedicated to innovation, our Surgical business unit is focused on... ...packages for submission to global regulatory agencies. Track timelines... ...relevant to medical devices, Class II and/or Class III devices...- ...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...
$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...- ...is seeking a Sr. Associate II, Regulatory Affairs Strategy in Lake Forest, California... ...activities for Alcon's Surgical portfolio, ensuring alignment with global regulations while fostering product... ...regulatory landscape of medical devices, strong technical writing skills...
- ...GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High... ...enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode)... ...our rapidly growing active implantable device portfolio. This role will be responsible...Hourly payWork at officeLocal areaRelocationShift work3 days per week
$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...$150k - $190k
...Principal Regulatory Affairs Specialist - Cardiac Ablation BIOTRONIK is one of the leading manufacturers... ...and vascular intervention. As a globally active company headquartered in Berlin... ...landscape for electrophysiology and ablation devices. Candidates without at least 7...Work at officeImmediate startWork from homeRelocation package$170k - $200k
...institutions to develop elegant medical devices. Our products are being used by... ...medical devices for stroke. As the premier global neurovascular platform always seeking... ...this opportunity - Senior Principal Regulatory Affairs Specialist Description The Sr. Principal...- ...Responsibilities Support US and EU regulatory submissions, ensuring protection of... ...years of hands-on experience in Regulatory Affairs ~ Experience supporting medical devices (Class II and/or Class III) ~ Exposure to global regulatory submissions and compliance...
$80k - $100k
...The Regulatory Affairs Specialist is responsible for investigating and supporting regulatory policy necessary... ...materials, changes to existing devices and documentation. Prepare submissions... ...requirements. Keeps current on global directives, harmonized standards and...Full timeWork at officeLocal areaMonday to FridayAfternoon shift$165k - $200k
...Sr. Technical Specialist – Regulatory Affairs & Global Certifications Manage key regulatory certification and compliance requirements for the Karma family of vehicles. The role requires regulatory experience in both pre‑production certification and post‑production compliance...Work at officeRelocation packageFlexible hours- ...and act with speed to advance global eye health. At Alcon, you’ll... ...part of Alcon's Quality & Regulatory Affairs function, a critical organization... ...activities for Alcon's Surgical portfolio. This onsite position... ...a focus on Retina medical devices within the Surgical...Hourly payTemporary workLocal areaWorldwideRelocation packageFlexible hours
$92k - $148.35k
...Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California (Hybrid/Flex schedule, 3 days on-site). Purpose The Senior... .... Prior experience with Class II or Class III Medical Devices strongly preferred. Experience interacting directly with the...Contract workTemporary workLocal areaFlexible hours$80.6k - $133k
...Overview The Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global product distribution and ensure... ...Knowledge of EU MDR/MDD, FDA medical device regulations, and other international...Flexible hours$76.59k - $120.35k
...Compliance Analyst in Lake Forest, California. The role involves managing import trade compliance, including HTS classification and regulatory adherence. Candidates should have over 5 years of experience in customs operations, strong analytical and communication skills,...$76.59k - $120.35k
ASSA ABLOY Sicherheitstechnik GmbH is seeking a Trade Compliance Analyst in Lake Forest, California. In this role, you will support and execute compliance programs, determine product classifications, and oversee entry reviews. Candidates should have 5+ years of experience...$84.72k - $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...- ...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...
- ...Regulatory Affairs Specialist 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...Work at office
- ...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...Contract workDay shift
- ...Job Summary The Regulatory Affairs Specialist (FDA, DEA)will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable... ...and state regulations related to pharmaceuticals, medical devices, and controlled substances. Key Responsibilities...
$60k - $65k
...Supports tasks related to Regulatory and Compliance activities including... ...pertaining to medical device and medical device manufacturing... ...Quality Assurance or regulatory affairs. One or more years of... ...Assurance/Regulatory Affairs Specialist MENTAL, PHYSICAL AND VISUAL...ApprenticeshipLocal area- ...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...
$70k - $90k
...Regulatory Affairs Specialist Job Category: Regulatory Affairs Requisition Number: REGUL001270 Posted: April 22, 2026 Full-Time Hybrid... .... Evaluates proposed product formula modifications for global regulatory impact. Liaises with international distributors...Full timeWork experience placementWork at officeRemote workShift work
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