Senior Regulatory Affairs Lead - Medical Devices (US/EU MDR)
Experis Technology Group
Experis Technology Group is seeking a Senior Regulatory Affairs Specialist in Santa Clara, CA, onsite. The role focuses on developing and improving regulatory processes, supporting registrations, and ensuring compliance across US and EU markets.
You will collaborate with cross-functional teams to drive regulatory readiness, submissions, and inspections, while adapting to evolving regulatory landscapes and product development needs.
#J-18808-Ljbffr- ...innovation empowers us to build a world... ...merit. Job Function: Regulatory Affairs Group Job Sub Function... ...best talent for a Senior Regulatory Affairs Program Lead to support our... ...electromechanical devices with software enabled... ...affairs experience in medical devices including...SeniorMedical deviceRemote workFlexible hours
- ...Sunnyvale, CA, seeks a Sr. Regulatory Affairs professional to lead regulatory strategies... ...-assisted surgery devices. You will develop regulatory... ...requires 8+ years in medical device regulatory affairs, deep knowledge of US FDA regulations and EU MDR, and strong cross-functional...Medical device
- ...Senior Regulatory Affairs SpecialistThis position will be working with multiple... ...regulatory landscape, including EU MDR. Identify opportunity for... ...-5 years of experiences in Medical Device Regulatory AffairsSkills:... ...inHave working knowledge in US and EU medical device...SeniorMedical devicePermanent employment
- ...of Position The Sr. Regulatory Affairs serve as the primary regulatory... ...changes. Influence and lead global regulatory... ...working in a medical device company (can be in combination... ...depth understanding of US Medical Device regulations and EU MDR, especially as it related...SeniorMedical deviceWorldwide
- ...Function of Position The Sr. Regulatory Affairs Specialist’s primary... .... Influence and lead global regulatory strategies... ...working in a medical device company (can be in combination... ...understanding of US Medical Device regulations... ...Canada guidance and EU MDR. • Regulatory working...SeniorMedical deviceLocal areaWorldwideFlexible hours
- ...SummaryThe Sr. Manager, Regulatory Affairs for the Digital Portfolio leads regulatory... ...software as a medical device (SaMD),... ...serves as the senior regulatory voice... ...requirements such as the EU AI Act.Ensure... ...leading US premarket submissions... ...Part 11), EU MDR, and software lifecycle...SeniorMedical deviceLocal areaWorldwideFlexible hours
$69.33 - $74.33 per hour
...4.33hr Job Overview: The Senior Regulatory Affairs Specialist will work with... ...regulatory landscape, including EU MDR. Identify opportunities... .... Working knowledge of US and EU medical device submissions. Experience... ...Cynet Systems Inc. is a leading technology staffing and workforce...SeniorMedical deviceTemporary workLocal area$130.7k - $261.3k
...of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...are recruiting for a Senior Regulatory Affairs Manager to join our... ...access.Support FDA, EU MDR/CE Mark, and other applicable... ...knowledge of US FDA Medical Device Regulatory...SeniorMedical deviceWork experience placementWorldwideShift work- ...The Sr. Manager, Regulatory Affairs for the Digital Portfolio leads regulatory... ...software as a medical device (SaMD), software... ...serves as the senior regulatory voice... ...requirements such as the EU AI Act.... ...success leading US premarket submissions... ...Part 11), EU MDR, and software...SeniorMedical deviceLocal areaWorldwideFlexible hours
$64.75 per hour
...Job Description Job Description Senior Regulatory Affairs Specialist Location: Santa Clara,... ...regulatory landscape, including EU MDR. Identify opportunities for regulatory... .... Have working knowledge of US and EU medical device submissions. Have experience supporting...SeniorMedical deviceContract workWork visa- ...is seeking a highly motivated Principal Regulatory Affairs Specialist to join our Vascular Division on-site in Santa Clara, CA. You will lead global regulatory strategies, prepare submissions... ...with QMS, ISO, and EN standards across US, EU, and international markets. #J-18808-...SeniorMedical device
$121.89k - $143.4k
...expert support for regulatory project... ...user’s needs, the Senior Regulatory Affairs Specialist (Labeling... ...registrations and variations.Lead authorship... ...experience in medical device fieldMinimum of 5... ...Title 21 of the US code of Federal Regulations... ...2007/47/EC) and EU Medical Device...SeniorMedical deviceFull timeWork experience placementWork at office- ...We are seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory... ..., recalls, advisory notices, and Medical Device Reporting (MDR). Lead or support Post-Market... ...registrations. Working knowledge of: EU IVDR 2017/746 FDA regulations ISO...SeniorMedical device
- ...Senior Regulatory Affairs SpecialistJoin us in pioneering breakthroughs in healthcare... ....Varian Medical Systems, a Siemens... ...role independently leads regulatory assessments... ...ownership of medical device submissions, strong... ...applications, and EU MDR technical documentation...SeniorMedical device
- ...Intuitive Surgical seeks a Senior Manager of Regulatory Affairs to lead regulatory strategy... ...for software-driven medical products, including... ...Determine device classification, qualification... ...success leading US premarket submissions... ...CFR 820, Part 11), EU MDR, software lifecycle,...SeniorMedical device
$90k - $180k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...contributor, the function of a Senior Regulatory Affairs Specialist (International)... ...all geographies outside the US and EU) submissions. Strategic Planning...SeniorMedical deviceWorldwideShift work- ...Intuitive Surgical in Sunnyvale, CA seeks a Senior Program Manager to lead the full lifecycle of medical device capital systems from concept to launch.... ...drive cross-functional teams, ensure regulatory compliance (FDA, EU MDR, ISO 13485), and coordinate manufacturing...SeniorMedical device
$90k - $180k
...Employees can qualify for free medical coverage in our Health... ...the design and provision of device and management solutions for... ..., the function of a Senior Regulatory Affairs Specialist (International)... ...all geographies outside the US and EU) submissions. Strategic...SeniorMedical deviceWork experience placementWorldwideShift work- Intuitive Surgical, Inc. seeks a Senior Project Manager to lead the full lifecycle of medical device endoscope development from... ...commercial launch. You will steward regulatory, sterilization,... ...rigor, while aligning with FDA/EU MDR/ISO standards and #J-18808-Ljbffr...SeniorMedical device
- ...Job Description Job Title: Senior Regulatory Affairs Specialist Location (On-... ...-5 years of experiences in Medical Device Regulatory Affairs... ...Have working knowledge in EU MDR Have working knowledge in... ...Have working knowledge in US and EU medical device submissions...Medical deviceContract workRemote work
$86.7k - $173.3k
...full timeCategory: Regulatory AffairsIndustry:... ...healthcare, with leading businesses and products... ...in diagnostics, medical devices, nutritionals and... ...Principal Regulatory Affairs Specialist to... ...applicable. Support EU MDR regulatory... ...requirements for US, EU (EU MDR), and...Medical deviceFor contractors- ...1278 Job Summary: Seeking a Senior Medical Device Quality & Compliance Engineer... ...Device Quality Systems, Regulatory Compliance, Design Transfer,... .... Roles & Responsibilities: Lead design transfer and production... ...Medical Device Regulation (MDR) Design Transfer Activities...SeniorMedical device
$148.7k - $297.3k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...seeking a Endovascular, Senior Marketing Manager (US Downstream) to join the... ..., Clinical, Medical Affairs, and Regulatory Affair to ensure successful...SeniorMedical deviceTemporary workShift work- ...Evaluation (CRE) Senior Scientist/Program... ...healthcare, with leading businesses and products... ...in diagnostics, medical devices, nutritionals and... ...performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product... ...2.7/1 Rev. 4 and MDR Article 61Solid understanding...SeniorMedical deviceWork experience placement
$109k - $185k
...Principal Regulatory Affairs SpecialistAt MiniMed, you can begin... ...the globe. You'll lead with purpose, breaking... ...guiding innovative medical devices and software through... ...across the business—US, EU, international regulatory... ...to the FDA, EU MDR, and other global regulatory...Medical deviceLocal areaRemote workFlexible hours- ...company in California is looking for a Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior staff. Strong...SeniorMedical device
$115.5k - $156.4k
...ventricular endocardial pacing device for heart failure. It's a... .... The Opportunity The Senior Regulatory Affairs Specialist represents the Regulatory... ...federal, and international medical device regulations and... ...regulatory bodies in the US and/or international regions...SeniorMedical deviceLocal areaFlexible hoursNight shift- ...Selectek, Inc. is seeking an experienced Senior Regulatory Affairs Specialist to lead global regulatory activities for its diagnostics, life sciences... ...have at least 3 years in regulatory affairs within medical devices or IVD, experience with international #J-18808-LjbffrSeniorMedical device
$76k - $86k
...fast-growing, publicly traded medical device company that is an industry... ...all applicable worldwide regulatory requirements as included in... ...ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required... ...by the Secretary of Veterans Affairs; or a person who was...SeniorMedical deviceFor contractorsWork at officeLocal areaRemote workWorldwide- IntelliPro is seeking an Analog Layout Engineer to lead full-chip and block-level layouts for power management ICs in a... ...cross‑continent team. You will translate discussions between US and China teams, place devices with attention to matching and thermal performance, and...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead - Medical Devices (US/EU MDR). Be the first to apply!
- senior living Santa Clara, CA
- senior associate vice president Santa Clara, CA
- senior app developer Santa Clara, CA
- senior manufacturing engineer Santa Clara, CA
- senior ml engineer Santa Clara, CA
- senior executive director Santa Clara, CA
- senior application support engineer Santa Clara, CA
- senior manager data analytics Santa Clara, CA
- senior devops Santa Clara, CA
- senior supply chain manager Santa Clara, CA



