Global Regulatory Affairs Specialist - Medical Devices
Jenavalve Technology
Jenavalve Technology is hiring a Senior Specialist for Regulatory Affairs in Irvine, CA with a strong focus on managing regulatory communication and submissions. The role requires substantial experience in medical device regulations, ensuring compliance with quality standards, and engaging with regulatory authorities. The successful candidate will have a Bachelor's degree in a scientific discipline and will contribute to the development of submissions and ongoing regulatory strategy. #J-18808-Ljbffr Jenavalve Technology
$92k - $138k
...here. Medtronic is a global leader in healthcare... ...developing innovative medical technologies that improve... ...team partners across regulatory, quality, engineering... ...Senior Regulatory Affairs Specialist supports regulatory... ...neurovascular medical devices. This role is responsible...Medical deviceFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough... ...- Innovation - Caring - Global Collaboration - Winning... ...growing active implantable device portfolio. This role will be... ...Affairs experience in the medical industry Prior experience...Medical deviceWork at officeLocal areaRelocation3 days per week
$95.8k - $159.6k
...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role,... ...Experience working with medical devices or other regulated healthcare...Medical deviceTemporary workLocal areaFlexible hours- ...Job Title: Senior Specialist, Regulatory Affairs Role Level: Individual Contributor... ...Description Summary: Responsible for global regulatory affairs... ...filings for investigational device authorizations and registrations... ...adverse event reporting, Medical Device Reports (MDRs),...Medical deviceWork at office
- ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual... ...Regulatory Affairs Specialist is a senior technical expert... ...for Class III cardiovascular medical devices. In this highly visible... ...ensuring alignment across global stakeholders and timelines....Medical deviceFull timeContract workRemote work3 days per week
- ...Scientific is partnered with an established medical device innovator developing life-changing technologies... .... As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions,...Medical device
$110.1k - $183.4k
Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse... ...years of regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related...Medical deviceTemporary workLocal areaFlexible hours- Job-ID31853494Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...Medical device
$95.8k - $159.6k
...or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this... ...working with medical devices or other regulated healthcare...Medical deviceFull timeFor contractorsLocal area- ...ConsultNet Technology Services and Solutions is hiring a Jr. Regulatory Affairs Specialist in Irvine, CA to support product development teams with... ...The role requires knowledge of 21 CFR QSR/cGMPs, ISO 13485, and experience with medical device regulations. #J-18808-Ljbffr...Medical device
$85k - $130k
Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory... ...capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory...Medical deviceWork experience placementLocal areaWorldwideFlexible hours- ...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...Medical deviceWork at office
- ...Regulatory Affairs Specialist (FDA, DEA) The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare... ...and state regulations related to pharmaceuticals, medical devices, and controlled substances. Key Responsibilities...Medical device
- ...Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies,... ...Quality System Standard. Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations...Medical deviceImmediate start
- ...Head of Global Regulatory Strategy About the Company Global biopharmaceutical company developing... ..., and providing oversight for medical device programs. This role requires a seasoned... ...a strong background in regulatory affairs, particularly within the biotechnology...Medical device
$80k - $95k
...Regulatory Affairs Specialist The Regulatory Affairs Specialist is responsible for coordinating and... ...that support the company's worldwide medical device business. This position supports... .... Duties and Responsibilities Global Product Registrations and Regulatory...Medical deviceWork at officeWorldwideWeekend workAfternoon shift$61.12k - $95.39k
...About Us Össur is a leading global provider of innovative mobility... ...The Role The Compliance Specialist is responsible for assisting... ...compliance program for Embla Medical’s Americas Business Units. This... ...regulations that impact medical device companies such as anti-kickback...Medical deviceFull timeWork experience placementLocal area$40 - $46 per hour
Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated... ...Industries This is an exciting opportunity to join a Global, industry leading company as a Trade Compliance Specialist. Responsibilities Generate SAP reports to...Medical deviceHourly pay$120k - $155k
Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies. About the Role... .... As a Regulatory Affairs Specialist, you will develop and... ...pharmaceutical or medical device industry...Medical deviceLocal areaFlexible hours$173k - $245k
...heart. Edwards Lifesciences is the leading global structural heart innovation company,... ...strengthen operational excellence and regulatory adherence. Oversight and management of... ...working in Healthcare Compliance in a large Medical Device, Pharmaceutical, and/or Biotech company...Medical deviceFull timeWork experience placementLocal area$19.5 - $21 per hour
...Now Hiring Medical Device AssemblersAre you detail-oriented, dependable, and looking for an opportunity to grow your career in medical device... ...and perform repetitive tasksWhy This Position?Work for a global leader in medical technologyClean, climate-controlled manufacturing...Medical deviceContract workTemporary workImmediate startWorldwide$182k
...building a deep understanding of the global market landscape, trends, customer... ...relationship with leaders across R&D, regulatory/legal, medical affairs, market research, operations,... ...experience in pharmaceuticals or medical devices, with experience in medical aesthetics...Medical deviceTemporary workLocal area$19 - $21 per hour
...Now Hiring Medical Device Assemblers Location: Irvine, CA Pay: $19-21/hr Shifts Available: Monday- Friday 6am- 3pm Monday-... ...and perform repetitive tasks Why This Position? Work for a global leader in medical technology Clean, climate-controlled manufacturing...Medical deviceWeekly payContract workTemporary workImmediate startWorldwideMonday to FridayShift workNight shift$120k - $140k
...20% About Kardion Kardion is a medical device company advancing innovative technology... ...headquarters in Irvine and strengthen our global operating model, we are seeking a... ...cross-functional partners in Quality, Regulatory, Clinical, R&D, Finance, and other teams...Medical deviceFull time$185k - $240k
A leading medical device company located in California is seeking a Director of Global Commercial Training. The role involves directing and overseeing commercial employee training programs to enhance effectiveness and ensure onboarding support. Candidates should possess...Medical device- ...champion progress, and act swiftly to impact global eye health. We foster an inclusive... ...role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products... ...to drive competitive advantageSupport medical device and/or pharmaceutical products,...Medical deviceHourly payFull timeTemporary workLocal areaRelocation packageFlexible hours
- ...strategies and commercial excellence for medical device products. You will influence regional... ...The role requires strong communications, global-market experience, and the ability to... ...cross-functional teams while navigating regulatory and compliance frameworks. #J-18808-...Medical device
- Terumo Neuro seeks a Sr. Director to shape the global manufacturing strategy and drive transformation across Smart Factory, AI Manufacturing... ...at the executive level. The role requires 15+ years in medical device manufacturing strategy, 7+ years of leadership, and a proven...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$100k - $135k
...stewarding Quality with your background in medical device quality assurance, a passion for... ...industries. We work collaboratively within our Global Quality Organization to deliver... ...What You Will DoEnsure compliance with regulatory requirements and internal procedures including...Medical deviceFlexible hours
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