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
- ...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
- 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
- ...Regulatory Affairs Specialist Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input... ...lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...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
- ...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
$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$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- Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports... ...Quality System Standard. Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device...Medical deviceImmediate start
- ...social, e-commerce, PR, and global markets. Creative Strategy... ...driven aesthetics aligned with regulatory requirements. Partner with... ...remains compliant with medical-grade skincare regulations, global... ...but Not Required: Medical device or pharmaceutical creative experience...Medical deviceFreelanceWork at officeRemote workShift work
$110.1k - $183.4k
...Staff International Regulatory Affairs Specialist Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly... ...affairs experience within the medical device, biotechnology, pharmaceutical, or...Medical deviceFull timeLocal area$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 areaWorldwide- ...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$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$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- ...Job Title Responsible for the production of high-quality medical devices within a cleanroom/manufacturing cell environment, performing assembly, repair, and test operations on catheters, pacemakers, ICDs, leads, and related medical device assemblies under close supervision...Medical device
$18 - $19.67 per hour
Medical Device Assembler 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 catheters under close supervision in a regulated manufacturing environment. Follow...Medical deviceHourly payFull timeContract workTemporary workWork experience placementImmediate startMonday to FridayDay shift$50 per hour
...An established leader in the medical device industry is seeking a... ...Engineer / Continuous Improvement Specialist to drive operational excellence... ...that operates under strict regulatory and quality standards. You... ...About Actalent Actalent is a global leader in engineering and...Medical deviceContract workTemporary work$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$100k - $135k
...Quality with your background in medical device quality assurance, a passion... ...collaboratively within our Global Quality Organization to... ...Do Ensure compliance with regulatory requirements and internal procedures... ..., Engineering, Regulatory Affairs For this role, we...Medical deviceFlexible hours$87k - $123k
...how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our... ...complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning...Medical deviceFull timeInternship$19 per hour
...Medical Device Assembler Location: Irvine, CA Hours: 5:00 AM to 1:30 PM | Pay: $19 per hour Responsibilities Produce high-quality... ...(QMS), Environmental Management Systems (EMS), and other regulatory requirements. Requirements High school degree or equivalent...Medical deviceHourly pay$90k - $120k
...Description Job Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington Beach, CA... ...safe, reliable, and innovative medical devices that improve patient outcomes.... ...critical in ensuring compliance with global regulatory requirements and...Medical deviceFull time$365k - $400k
...and collaborative SVP, Marketing to lead our global marketing efforts and drive continued growth in the medical device and healthcare technology industry.... ...Collaboration: Partner closely with Sales, R&D, Regulatory Affairs, and Clinical teams to align marketing efforts...Medical devicePart timeWork at officeLocal areaWorldwideFlexible hours$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 device$19 per hour
...mechanical assembly and clean room device assembly and packaging for medical device products. This role requires... ...standards to maintain product quality and regulatory compliance. Job Type & Location... ...is an Allegis Group company, the global leader in workforce and business...Medical deviceWeekly payContract workTemporary workMonday to Thursday3 days per week- ...of Glidewell Dental. We are seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high‑impact submissions... ...related files. Maintains company registrations and device listings in the US, Canada, and other countries. Performs...
- ...leading technology firm in California is seeking a Trade Compliance Specialist responsible for the ECCN and HTS classification of technology... ...U.S. Export Control Laws, the ability to navigate intricate regulatory standards, and proficient technical skills in analyzing...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist - Medical Devices. Be the first to apply!
- compliance analyst Irvine, CA
- regulatory compliance analyst Irvine, CA
- coding compliance specialist Irvine, CA
- compliance associate Irvine, CA
- regulatory compliance specialist Irvine, CA
- regulatory affairs specialist Irvine, CA
- compliance consultant Irvine, CA
- senior compliance officer Irvine, CA
- senior compliance analyst Irvine, CA
- healthcare compliance officer Irvine, CA



