MedTech Regulatory Affairs Specialist FDA/CE Submissions
RAPS Institute
Apreo Health is seeking a Regulatory Affairs Specialist to support regulatory submissions and ensure compliance with FDA and EU MDR standards. This onsite position is located in Menlo Park, California. The ideal candidate will have a minimum of 2 years' experience in medical device regulatory affairs, including FDA Class III device experience. Responsibilities include preparing document packages for submissions and managing regulatory plans for new products. #J-18808-Ljbffr
$106k - $170.2k
...Senior Regulatory Affairs Specialist Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category... ...devices, prepares regulatory documentation for submissions to European Notified Bodies, FDA, and other authorities, and ensures compliance with...SuggestedWork at officeLocal areaImmediate startRemote workFlexible hours$145k - $167k
...imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field,... ...The Role Job Title : Senior Regulatory Affairs Specialist Location: Palo Alto, CA or Guilford... ...responsible for ensuring regulatory submissions and registrations are authored and...SuggestedWork experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week$106k - $170.2k
6267-Auris Health Inc. Legal Entity is seeking a Senior Regulatory Affairs Specialist in Santa Clara, California. This role focuses on ensuring compliance with regulatory agencies for healthcare products, requiring a minimum of 4 years of relevant experience and a Bachelor...Suggested- ## Principal Regulatory Affairs SpecialistApplylocations: California... ...Regulatory Affairs Specialist provides regulatory... ...preparation of regulatory submissions and for the... ...ensure compliance with FDA and international regulations... ...Documentation for Europe (CE Mark) for new products...SuggestedWork at office
$100k - $160k
...National Labor Compliance Specialist The National Labor Compliance Specialist is responsible for administering and supporting national... ...validate, and approve Certified Payroll Reports and related submissions for accuracy, completeness, timeliness, and compliance with...SuggestedHourly payApprenticeshipFor subcontractorLocal area$75k - $120.75k
...expertise in Innovative Medicine and MedTech, we are uniquely positioned... ...for a Quality Compliance Specialist II – Shockwave Medica l to... ...System Regulations (QSR) and FDA requirements, the Quality... ...Systems (QMS), Quality Standards, Regulatory Environment, Report Writing...Local areaImmediate start- ...searching for an experienced regulatory professional to work within the... ...the Sr. Director, Regulatory Affairs (CDx), the successful... ...history of successful regulatory submissions, registrations, 510(k)’s, and... ...regulatory bodies, especially the FDA. The candidate must have...
$120k - $150k
...Certificates, Waivers & COAs Partner closely with engineering and flight test teams to ensure compliance alignment early in design Regulatory Engagement Serve as primary Pivotal representative to: Aeronautical Authorities including FAA (and offices including AIR, AFS,...Work at officeLocal area- ...Regulatory Affairs Specialist (NMPA) This position will partner with the in-country RA team as well as... ...ensure the deliverables prepared for NMPA submission are compliant. Coordinate and... ...standards, as well as fundamental US FDA requirements posed on medical device....For contractorsLocal area
$55 - $59 per hour
...Senior Regulatory Affairs Specialist Build your future with Volt! Volt is immediately hiring for Senior Regulatory Affairs Specialist in Santa... ...regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance...Hourly payFull timeContract workTemporary workWork experience placementLocal areaImmediate start$90k - $180k
...Senior Regulatory Affairs Specialist Abbott is a global healthcare leader that helps people live more... ...approval. Determine and communicate submission and approval requirements.... ...submissions. Experience interacting with US FDA and EU Notified Body. Experience...Work experience placementWorldwide$115.86k - $133.01k
...Transfer and Tangible Research property Agreements, draft language that complies with University, Federal and other sponsors and other regulatory policies, requirements, and conditions. Negotiate other research‑related agreements that involve intellectual property,...Hourly payFull timeContract workCasual workWork at officeRemote work$225k - $275k
...genetic diseases. Who You Are You are an experienced regulatory affairs professional with expertise in early clinical development... ...Lead and contribute directly to the planning, preparation, and submission of high-quality regulatory submissions (e.g., IND, CTA),...Flexible hours$185k - $205k
...Pharma is looking to hire an experienced Associate Director, Regulatory Affairs Clinical Strategy to join our team. This is an exciting... ...Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements...Temporary workFlexible hours- ...BCG Attorney Search is seeking a mid-level associate for its Life Sciences and Healthcare Regulatory practice in Palo Alto, CA. The role involves representing hospitals in regulatory matters, advising healthcare providers on compliance, and conducting legal research in...
- Senior GRC Analyst Palo Alto, California Workato delivers enterprise infrastructure for the agentic era, redefining iPaaS and helping enterprises unify data, applications, processes, and AI into a single, governed platform. A leader in Enterprise MCP and trusted ...Remote workFlexible hours
$40 - $70 per hour
Title: Compliance Analyst Location: Remote US - Must be available in PST hours Duration: 12+ months Compensation: $40-70/hr Work Requirements: US Citizen, GC Holders or Authorized to Work in the U.S. About this Featured Opportunity...Local areaRemote workFlexible hours$49.04 - $66.35 per hour
Wilson Sonsini is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. We represent companies at every stage of development, from entrepreneurial start-ups to multibillion-dollar global corporations, as well as the venture firms...Hourly payWorldwide- ...BCG Attorney Search is seeking a junior to mid-level associate with 3-5 years of regulatory experience in the gaming space to join their Menlo Park, CA practice. The role involves supporting partners in providing compliance advice to gaming operators and technology providers...Flexible hours
- Micro1 is seeking a Building Code Compliance Expert to join their team remotely. In this contractor role, you will ensure compliance with building codes and contribute to AI training projects through accurate insights on permitting and construction compliance. The ideal...Remote jobFor contractors
$25 - $30 per hour
Dart Solutions is seeking a Pharmacy Compliance Analyst to support the 340B program within a hospital group. This entry-level position involves compliance auditing and monitoring under supervision. The ideal candidate will have a Bachelor’s Degree and be proficient in EPIC...Remote jobHourly payWork at office- Job Overview A law firm seeks a mid-level associate for its Life Sciences and Healthcare Regulatory practice in Palo Alto, CA. The practice provides comprehensive assistance in healthcare provider/supplier and life sciences product regulation, serving a diverse clientele...
$50 - $55 per hour
Job Title: Senior Regulatory Specialist Location: 3200 Lakeside Drive, Santa Clara, CA 95054-2807... ...Overview Seeking a Senior Regulatory Affairs Specialist to support global regulatory... ...Global Compliance (MDR, International Submissions) Key Responsibilities Lead end-to-end...Hourly pay- Compliance Specialist III This role supports quality and regulatory compliance activities within a medical device manufacturing environment. The Compliance Specialist... ...procedures and external standards, including FDA and global quality regulations. This position is suited...Work at office
- Mentor Technical Group is seeking a candidate for a role focused on technical support in the FDA-regulated life sciences industry. Responsibilities include managing CMMS for asset lifecycle, scheduling calibrations, and environmental monitoring. Candidates should have experience...
- ...technology company is seeking a Complaints Specialist II in Santa Clara, CA. The role requires ensuring compliance with regulatory standards for medical devices. Responsibilities... ...compensation and substantial benefits are offered. #J-18808-Ljbffr Johnson & Johnson MedTech
$57 - $67 per hour
...Quality Compliance/Labeling Specialist Adecco Healthcare & Life Sciences is hiring for... ...standards, and strong commitment to global regulatory compliance. This is a contract... ...while collaborating closely with Regulatory Affairs, Quality, Engineering, and Marketing...Hourly payWeekly payContract workTemporary workLocal area- ...collection, coordination, and summary of global regulatory intelligence that pertains to the... ...development, clinical strategy, submissions, and lifecycle management. Help establish... ...Minimum 5 years of experience in regulatory affairs and bachelor’s degree in a relevant...Work at officeLocal areaFlexible hours
- ...Marubeni America Corporation in Palo Alto is seeking an Administration & Logistics Specialist responsible for coordinating semiconductor product shipments according to customer requirements. The role includes preparing invoices, managing accounts receivable and payable...
$25 - $35 per hour
...coordinates compliance processes, maintains accurate and audit-ready records, and helps ensure adherence to organizational policies, regulatory requirements, and BGCA standards. Reporting to the Senior Director of People Operations, with a dotted-line partnership to the...Full timeWork experience placementSeasonal workWork at officeLocal areaRemote workMonday to FridayShift workDay shift
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