Remote Senior Regulatory Affairs Specialist (Medical Devices)
Siemens Healthineers AG
- Remote job
Siemens Healthineers AG is seeking a Senior Regulatory Affairs Specialist for a remote role in the United States. You will prepare and maintain regulatory submissions, advise on design control, and ensure QMS alignment across cross‑functional teams. This position emphasizes compliance with US/EU medical device and IVD regulations and requires precise documentation and audit readiness. The role offers a collaborative environment with global teams, ongoing training, and opportunities to lead #J-18808-Ljbffr Siemens Healthineers AG
$92k - $138k
...an immediate opening for a Senior Regulatory Affairs Specialist with our Quality division. This role will be remote. Under limited supervision,... ...regulatory strategies for new devices, new launch markets, and... ...chemistry, etc.), engineering, medical technology, regulatory...Remote workSeniorMedical deviceMinimum wageFull timeLocal areaImmediate startWorldwide$138k - $192k
...worldwide. In this pivotal role as Senior or Principal Regulatory Affairs Specialist, you will support business... ...regulatory affairs experience in medical devices, digital health, and/or SaMD (Software... ...Requirements This role is a remote position with expected travel....Remote workSeniorMedical deviceWork experience placementWorldwideNight shift- ...Senior Regulatory Affairs Specialist Give hope. Give health. Make your mark in the fight against cancer... ...for expanding the reach of Accuray's medical device products in global markets by... ...Pacific region. The work location is remote based on the supported markets....Remote workSeniorMedical devicePermanent employment
$55.03 per hour
...from Infosoft, Inc. Job Title: Senior Regulatory Affairs Specialist Pay Rate: $50 to $55.03/HR Duration... ...6 months Location: Irvine, CA/Remote (9 am to 6 pm PST time zone due to... ...) Our Client is a Global medical device Manufacturer. We are looking for...Remote workSeniorMedical deviceFull timeWork at office- ...10(k) submissions Owning regulatory strategy for product changes... ...: 5+ years of Regulatory Affairs experience in medical devices Direct hands-on... ...MA Some flexibility for remote work on Fridays Occasional... ...currently operating at a Senior level and ready for greater...Remote workSeniorMedical device
- ...Senior Regulatory Affairs Specialist Remote - United States Our mission at Oura is to empower every person to own their inner potential. Our award... ...strategy/operations for our Software as a Medical Device (SaMD) portfolio. This role will help drive compliant...Remote workSeniorMedical deviceWork at officeLocal areaFlexible hours
- Position Senior Regulatory Affairs Specialist - Durham, NC - Bioventus LLC. Responsibilities Author and... ...or related role within the medical and/or diagnostic device industry. 3+ years of experience... ...model: 3 days in office and 2 days remote within commuting distance. National...Remote workSeniorMedical deviceWork at office
$80 - $100 per hour
...- $100.00/hr Quality, Regulatory & R&D Staffing Expert |... ...MedTech business to hire a Senior Regulatory Affairs Specialist (Contractor). This is a... ...(full‑time) Location: Remote with some travel to HQ in... ...variety of RA tasks across Medical Devices Ensuring compliance...Remote workSeniorMedical deviceHourly payPermanent employmentFull timeContract workFor contractors$83k - $103.7k
...POSITION SUMMARY: The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory... ...required to market new or modified medical devices and in vitro diagnostic devices in... ...due to cost of labor considerations. Remote USA $83,000 — $103,700 USD OUR OPPORTUNITY...Remote workSeniorMedical deviceWork at officeImmediate start$83k - $103.7k
...steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in the United States. The... ...regulatory strategy and market access of medical devices and in vitro diagnostic (IVD)... ...continued market access. This is a remote opportunity for an experienced regulatory...Remote workSeniorMedical deviceFull timeImmediate start- ...an innovative, fast-paced, global medical device company with a mission to save lives... ...Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing... ...Regulatory Affairs. This is a flexible Remote or hybrid on-siteposition in...Remote workSeniorMedical deviceFor subcontractorFlexible hours
$35 - $40 per hour
...Regulatory Affairs SpecialistRemote - Memphis preferred, open to remote candidates so please specify location/time zone on resume24 Month Contract Pay: $35/hr -... ...guidance documents, country-specific requirements, medical devices and medical terminologyPlan, lead and support...Remote workSeniorMedical deviceContract work$150k
...company in the world to focus solely on medical device materials for safety. NAMSA started... ...the development and execution of global regulatory strategies for medical devices, in vitro... ...one or more areas, including regulatory affairs, clinical strategy, non-clinical testing...Remote workSeniorMedical deviceLocal area- ...one of the largest global medical technology companies in the... ...Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation... ...weekly in Covington, and remotely Friday on a weekly basis.... ...experience within the medical device industry. Experience...Remote workSeniorMedical deviceWork at officeShift workDay shift
$100k - $105k
...Senior Regulatory Affairs Specialist Location: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) Company: VB Spine Looking... ...among the largest family-owned medical technology companies in the... ...the FDA-regulated medical device industry Hands-on...Remote workSeniorMedical deviceWork at office- ...Regulatory Submission Coordinator Role Summary: Responsible for global coordination and... ...documents/packages for Baxter medical devices. The role involves reviewing technical/... ...medical devices / healthcare regulatory affairs. Knowledge of U.S. and OUS device regulations...Remote workMedical device
- Job-ID32452153Reference26-00983Remote50% Remote Job DescriptionAs a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region... ..., Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)...Remote workSeniorMedical device
$35 - $36 per hour
...Job Title: Regulatory Affairs Specialist Location: Carlsbad, CA Pay Range: $35.00... ...: 3 days on-site / 2 days remote) Duration: 4 months+ Qualifications... ...of international medical device regulations Ability to work... ...proactively Additional Details: Seniority Level: Associate...Remote workMedical deviceTemporary workShift work$115k - $130k
...seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support the BrioVAD® Left... ...Partner with Clinical, R&D, Quality, Medical Affairs, and other cross-functional... ...investigator communications, labeling, device changes, and other study-related documentation...SeniorMedical device$90k - $180k
...with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,0... ...Opportunity As an individual contributor, the function of a Senior Regulatory Affairs Specialist (International) is to provide support for the...SeniorMedical deviceWorldwideShift work- Our client is an innovative medical device company looking to add an experienced Regulatory Affairs professional to their growing team. This individual will play an important role in supporting regulatory initiatives and helping advance medical device products through development...SeniorMedical device
- Job Title:Senior Regulatory Affairs Specialist Location:Santa Clara, CA - 100% Onsite 12 Months Contract + Extensione Pay Range: $60/hr to $66/hr... ...activities. What's Needed? 3-5 years of experience in Medical Device Regulatory Affairs. Working knowledge of EU MDR. Working...SeniorMedical deviceContract work
$106k - $130k
...AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of... ...professionally and personally. POSITION SUMMARY: The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain...SeniorMedical deviceTemporary workWork experience placementWork at officeLocal areaWorldwide- ...To support the Cloud Platform Agile Release Train in a regulated medical device environment, the remote Senior Release Train Engineer will manage PI Planning, coordinate multiple Agile teams, and drive execution while ensuring alignment on priorities and tracking delivery...Remote workSeniorMedical device
- ...Regulatory Affairs Specialist We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our team in Canada. The... ..., and guidelines, including the Food and Drugs Act, Medical Devices Regulations, Natural Health Products Regulations, and other...Remote workMedical deviceWork at office
- ...Senior Regulatory Affairs SpecialistJoin us in pioneering breakthroughs in healthcare... ...contributions.Varian Medical Systems, a Siemens Healthineers... ...Senior Regulatory Affairs Specialist in either Palo Alto, CA or... ...ownership of medical device submissions, strong regulatory...SeniorMedical device
- Overview We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy, submissions, and product lifecycle activities. This is a high-impact opportunity to work cross-functionally...SeniorMedical deviceLocal area
- ...staffing and recruitment specialist providing contract and... ...00007073 Job Title: Senior Recruiter III (... ...pm, M-F (Will consider remote work but must be willing... ...who have cutting edge medical technology background.... ...experience in the Medical Device industry , with proven...Remote workSeniorMedical devicePermanent employmentFull timeContract workTemporary work
- ...GMP-regulated environment, the full-time Senior Validation Engineer will develop,... ...documentation, ensuring compliance with regulatory requirements and internal quality standards... ...the biotechnology, pharmaceutical, or medical device industry Strong knowledge of FDA cGMP...Remote workSeniorMedical deviceFull time
- ...countries and regions. Position Summary The Senior Regulatory Affairs Specialist is responsible for leading and... ...regulatory activities for assigned devices and projects throughout the product... ...experience in regulatory affairs within the medical device industry, including...SeniorMedical deviceFlexible hours
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