Strategic Regulatory Affairs Lead - Medical Devices
MillenniumSoft Inc
A leading medical devices company is seeking a Senior Regulatory Affairs Coordinator in Irvine, CA. The candidate will support regulatory submissions, develop strategies, and provide guidance to teams on product registrations. A Bachelor's degree in a scientific discipline and 5-7 years of experience are required. Strong communication, analytical skills, and detail orientation are essential. The role is full-time with an estimated duration of 12 months on a contract basis. #J-18808-Ljbffr MillenniumSoft Inc
$92k - $148.35k
Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to provide regulatory support... ...Irvine, California. The role involves strategic guidance for product compliance,... ...alongside comprehensive benefits including medical, dental, and 401(k) plans. #J-18808-...Medical device$66.8k - $75k
A global medical device solutions provider is looking for an experienced program manager to lead complex client projects in Irvine, California. The successful candidate will have over 7 years of relevant experience in Med Tech, engage effectively with stakeholders, and...Medical deviceWork at office- 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
- A medical devices company is seeking a Regulatory Affairs Coordinator with 5-7 years of experience in the medical device industry. You will support regulatory submissions and collaborate on change notifications while ensuring compliance with global regulations. The ideal...Medical deviceFull timeContract workWork at officeDay shift
$102k - $177.1k
...Marketing Job Sub Function: Strategic Marketing Job Category:... ...commercialization of life changing medical devices for the treatment of stroke and neurovascular... ...-functional partners including regulatory, clinical affairs, professional and commercial education...Medical deviceLocal areaImmediate startRemote work- A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology. The role requires 8-10 years of experience in US and EU regulatory affairs and strong project management skills...Medical deviceFull timeRemote work
$126k - $178k
Edwards Lifesciences in California is seeking a Regulatory Affairs professional, with a Bachelor’s Degree and at least 8 years of related experience. Key responsibilities include representing regulatory functions on product development teams, preparing submissions for...Medical device- A leading medical technology company in Irvine, CA is seeking a Product Security leader to guide... ...cybersecurity for innovative medical devices. The role involves overseeing security measures, managing risks, and ensuring regulatory compliance, with a focus on cloud-connected...Medical device
- ...seeking a Quality System Specialist to lead the Quality Management System (QMS) for... ...operations. The role involves ensuring regulatory compliance, managing quality oversight,... ...degree, 3-5 years of experience in the medical device industry, and proficiency with ERP systems...Medical device
- A leading medical devices company is seeking a Regulatory Affairs Specialist to join their team based in Irvine, CA. The candidate will be responsible for planning... ...product approvals and contribute to the strategic regulatory pathway development. Ideal applicants...Medical device
- A medical device company in California is seeking a Materials Manager to oversee procurement, inventory, and distribution of materials used in spinal surgery. The role ensures compliance with FDA and ISO standards while developing strong supplier relationships and managing...Medical device
- ...Position : Regulatory Affairs Specialist Location : Irvine, CA Duration : 10 Months... .../week : 40.00 1st Shift Client : Medical Devices Company Job Category : Clinical... ...medium complexity Contributes to the strategic direction of regulatory pathway development...Medical deviceContract workDay shift
- ...Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability...Medical device
- ...Regulatory Affairs Representative Responsibilities: Represent Regulatory Affairs on cross... ...functional project teams and provide strategic input and technical guidance on... ...and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability...Medical device
- Diality seeks a Product Manager to lead downstream marketing for the Moda-flx Hemodialysis System. This role involves collaboration... ...’s degree and a minimum of 5 years in marketing within the medical device industry, strong organizational skills, and the ability to thrive...Medical device
- Position Coord 3, Regulatory Affairs - Exp in Medical Device Industry (Req Min 5-7 Yrs Exp) Location Irvine, CA Duration 12 Months Total Hours/week 40.00 Shift 1st Shift Client Medical Devices Company Level of Experience Senior Level Employment Type Contract on...Medical deviceContract workWork at officeShift workDay shift
- ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns... ...experience reports, providing strategic product direction to teams on interaction... ...Ensuring rapid and timely approval of new medical devices and continued approved status of...Medical deviceVisa sponsorshipRelocation package
$125k - $130k
...For 45 years, Balt has been leading the way - collaborating... ...institutions to develop elegant medical devices. Our products are being... ...this opportunity - Senior Regulatory Affairs Specialist Description:... ...partners and demonstrates strategic thinking and creativity in...Medical deviceWork at office$70k - $90k
...mechanical design and development of patient monitoring devices. Key tasks include 3D CAD modeling and leading cross-functional teams to ensure successful product... ...a B.S. in Mechanical Engineering, experience in medical device design, and strong problem-solving skills....Medical device$70k - $90k
...design and development of new and sustaining patient monitoring devices. The role involves technical leadership and cross-functional... ...will have strong mechanical design experience, particularly with medical devices, and proficiency in 3D CAD modeling (SolidWorks). The position...Medical device- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you... ...growing active implantable device portfolio. This role will be... ...lines, special projects or strategic initiatives Required Qualifications... ...Affairs experience in the medical industry Prior experience...Medical deviceWork at officeLocal area3 days per week
$145k - $205k
Edwards Lifesciences in Irvine, California, seeks a candidate to lead imaging-based patient screening efforts. The ideal applicant will have at least 8 years of experience in the medical device sector, with a strong background in advanced cardiovascular imaging and analytical...Medical device$137k - $235.75k
Johnson & Johnson in Irvine, California is looking for a Programming Leader in the Medical Devices Sector. This role entails leading a team of SAS and R programmers responsible for statistical deliverables for clinical trials. The ideal candidate will have over 8 years...Medical device$145k - $205k
Edwards Lifesciences Belgium is looking for a functional lead for imaging-based patient screening in Irvine, California. This role... ...or Life Sciences and at least 8 years of experience in the Medical Device or Healthcare industry. The position focuses on collaborative...Medical device- A mid-level contract position in a medical devices company based in Irvine, CA, for Quality Document Systems Management. The role involves reviewing quality assurance procedures, managing documentation, and ensuring compliance with standards. The right candidate will have...Medical deviceContract work
$159.35k - $254.97k
...seeking a Global Finance Manager in Irvine, California. The role involves being a strategic finance partner by providing financial reporting and insights that influence decision-making. You'll lead financial planning and guide a high-performing team. Candidates should have a...Flexible hours- Applied Medical in Lake Forest, CA is seeking a Manufacturing Team Leader to oversee production operations, guide team members, and ensure the efficient manufacturing of high-quality medical devices. This role involves collaborating with cross-functional teams to implement...Medical device
$92k - $130k
...Regulatory Affairs Specialist Make a meaningful difference to patients around the world.... ...regulatory requirements necessary for strategic and contingency planning, including developing... ...of global regulations relevant to medical devices, Class II and/or Class III devices...Medical device- A leading technology company is seeking an NPD Program Manager to oversee the product development life cycle in Irvine, California... ...6 years' experience in managing complex NPD projects in the medical device industry, focusing on a mix of software, firmware, and hardware...Medical device
$92k - $130k
...for global operations. Key responsibilities include providing leadership on complex labeling projects, ensuring compliance with regulatory standards, and contributing to continuous process improvements. The ideal candidate should have a Bachelor's Degree and 5 years of...Medical device
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