Global Regulatory Affairs Specialist - Medical Devices
JenaValve Technology, Inc.
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
- Regulatory Affairs Specialist II (hybrid) The Regulatory Affairs Specialist III, will provide administrative... ...in the application of the European Medical Devices Directive (93/42/EEC as amended by... ....Previous experience working with globally dispersed affiliates and...Medical deviceFull timeWork at officeWorldwideDay shift
$110.1k - $183.4k
...: Hybrid or OnsiteStaff International Regulatory Affairs SpecialistIrvine, CAIn this International... ...Affairs role, you will ensure global product registrations move efficiently... ...regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related...Medical deviceFull timeFor contractorsLocal area- ...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
- ...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
- ...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...Medical deviceWork at office
$92k - $148.35k
...recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function:... ...a Senior Regulatory Affairs Specialist. This role will work a... ...relevant function such as Quality, Medical, Clinical, R&D.Demonstrated... ...II or Class III Medical Devices strongly preferred.Experience...Medical deviceFull timeContract workTemporary workLocal areaImmediate startFlexible hours3 days per week- ...A reputable medical devices company is seeking a Senior Regulatory Affairs Coordinator for an onsite position in Irvine, CA. The role involves supporting US and EU regulatory submissions, developing regulatory strategies, and providing guidance on registration. Candidates...Medical deviceContract workWork 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
$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... ...Kingdom. As a Regulatory Affairs Specialist, you will develop... ...pharmaceutical or medical device industry...Medical deviceLocal areaFlexible hours$61.12k - $95.39k
...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... ...that impact medical device companies such as anti-kickback...Medical deviceFull timeWork experience placementLocal area$102k - $177.1k
...MedTech Neurovascular is recruiting for a Global Strategic Marketing Manager, located... ...commercialization of life changing medical devices for the treatment of stroke and... ...cross-functional partners including regulatory, clinical affairs, professional and commercial education...Medical deviceFull timeLocal areaImmediate start$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$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$108k - $153k
...expertise can change a patient’s life. Our Global Operations & Quality team plays a... ...while developing your knowledge of the medical device industry. Whether your work includes strategic... ...teams, including Operations, Quality, Regulatory, Supply Chain, and R&D, to resolve...Medical deviceFull time- ...Medical Device Assembler Kelly Services, the leader in Manufacturing Career Placement is proud to announce we are now partnering with Johnson... ...of heart rhythm disorders. Johnson & Johnson is a global leader in cardiac electrophysiology, providing advanced catheter...Medical deviceImmediate startWorldwideDay shift
- ...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 work
$64.8k - $97.2k
...here. Medtronic is a global leader in healthcare technology... ...developing innovative medical technologies that... ...Trade Operations Specialist , you will serve as a... ...importation of medical devices worldwide. This role is... ...efficiency, consistency, and regulatory compliance. Minimum...Medical deviceH1bWork at officeLocal areaWorldwideFlexible hours- Regional Sales Manager (Medical Device) Japanese Bilingualð Irvine, CA (Hybrid)ð Competitive Salary 100-150K (including Bonus) + Excellent Benefitsð Medical Device / Healthcare Industryð Global Company EnvironmentA global manufacturer and supplier within the medical device...Medical deviceContract workWork at officeRemote work
$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$100 per hour
...Director of Continuous Improvement A global leader in the medical device industry is seeking a Director of Continuous Improvement to spearhead Operational... ...sector, requiring adherence to high standards and regulatory compliance. Job Type & Location This is a Contract to...Medical deviceContract workTemporary work$19.5 - $21.5 per hour
...Our client, a leading organization in the medical device manufacturing industry, is seeking a MEDICAL ASSEMBLY TECHNICIAN to join their team... ...Jefferson Wells. ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in...Medical deviceWeekly payFull timeTemporary workShift workWeekend work$18 - $19.67 per hour
...Medical Device Assembler Irvine, CA Immediately Temporary/Contract Description Come create your career with Volt Volt is immediately hiring a Medical Device Assembler in Irvine, CA 92614 As a Medical Device Assembler, you will: Perform assembly, repair, and testing of...Medical deviceHourly payFull timeContract workTemporary workWork experience placementImmediate startMonday to FridayDay shift$18 - $21 per hour
...company policies and procedures to maintain regulatory and quality compliance. Properly... ...environment, preferably within the medical device industry. ~ Experience with documentation... ...is an Allegis Group company, the global leader in workforce and business solutions...Medical deviceWeekly payContract workTemporary workDay shift$19 per hour
...Job Title: Medical Device Assembler Location: Irvine, CA Hours: 5:00 AM to 1:30 PM | Pay: $19 per hour Responsibilities:... ...Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Requirements: High school degree or equivalent...Medical deviceHourly pay- ...critical role, you will lead regulatory strategies, product... ...team of talented regulatory affairs professionals to drive timely... ...functionally with Clinical, Global Regulatory Affairs counterparts... ...regulatory requirements for medical devices (including IEC/ISO standards...Medical deviceWork at office
$21 - $24 per hour
...Medical Device Assembler Eastridge Workforce Solutions is hiring several long-term temporary employees for a leading medical manufacturing company in the Irvine area. If you are looking to grow your skills in a fast-paced environment this could be the right opportunity...Medical deviceHourly payTemporary workLocal areaMonday to Friday
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