Remote Senior Regulatory Specialist - IVD FDA Submissions
Planet Pharma
A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical Science and expertise in regulatory affairs, particularly in IVD product development. The specialist will collaborate with R&D teams, shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing and communication skills are essential. Enjoy competitive compensation and flexible work arrangements. #J-18808-Ljbffr
$50 - $67 per hour
...$50.00/hr - $67.00/hrSr. Regulatory SpecialistFully remote in PST time zone ONLYDo not... ...is a key contributor to FDA submissions (PMA/510(k)) and requires... ...writing, knowledge of IVD product development requirements... ...analytical documentation.Seniority levelMid-Senior...Remote workSenior- ...Regulatory Affairs Specialist Provide regulatory guidance in IVD assay studies. The incumbent in this role will provide pre-market... ...coordinating team inputs for submissions. Must have the ability to... ...communications with regulatory bodies like FDA, Health Canada, notified bodies...Remote workSeniorWorldwide
$55.03 per hour
...Infosoft, Inc. Job Title: Senior Regulatory Affairs Specialist Pay Rate: $50 to $55.03/HR... ...months Location: Irvine, CA/Remote (9 am to 6 pm PST time... ...products. Create regulatory submissions (exercising judgment to protect... ...Affairs Specialist, IVD California, United States...Remote workSeniorFull timeWork at office$115.5k - $156.4k
...Regulatory Affairs Representative Represents the Regulatory Affairs... ...technical documentation/submissions for regulatory approval in the... ...approximately 25% of the time for a remote arrangement. Travel may... ...team behind the world's first FDA approved, leadless left ventricular...Remote workSeniorLocal areaFlexible hoursNight shift- Intuitive in Sunnyvale, California is seeking a Regulatory Affairs Specialist to serve as the primary regulatory representative on... ...role involves developing regulatory pathways for FDA and Canada, authoring submissions, and liaising with global counterparts. Required skills...Senior
$95k - $105k
...Laboratories in San Diego is seeking a Regulatory Affairs Specialist III to oversee the preparation of regulatory submissions for medical devices. The ideal... ...candidate will have significant experience in IVD and be familiar with FDA and CE regulations. The role involves...Senior- A clinical research organization is seeking a Senior Regulatory Specialist to provide regulatory oversight for clinical trials. This remote position involves preparing and coordinating IRB submissions, ensuring regulatory compliance, and facilitating training for staff...Remote workSenior
$80 - $100 per hour
....00/hr Quality, Regulatory & R&D Staffing Expert... ...business to hire a Senior Regulatory Affairs Specialist (Contractor). This... ...to complete first submissions and filings in 2026... ...‑time) Location: Remote with some travel to... ...including submissions to FDA Collaborating...Remote workSeniorHourly payPermanent employmentFull timeContract workFor contractors- ...Position: Senior Regulatory Specialist (Remote) Location: Houston, TX Job Id: 1194 # of Openings: 1 Senior Clinical... ...the process for accurate and timely submission of Institutional Research Board (IRB... ...(such as but not limited to: FDA form 1572, protocol signature page,...Remote workSeniorWork at officeLocal area
- ...Senior Regulatory Affairs Specialist CooperSurgical is a leading fertility and women'... ...colleagues. The position is remote but based out of UK. The... ...authorities primarily focus on FDA 510(K) and UK/EU MDR. You... .... Medical device submissions to US and UK/EU Drive renewals...Remote workSeniorFull timeLocal areaShift work
- ...Job Title - Senior Regulatory Affairs Specialist Location - Franklin Lakes, NJ [No Remote position. Hybrid model] Duration – 12+ Months... ...customer exposure, global submission activity, regulatory... ...Notified Body, Health Canada, FDA) for technical requirements...Remote workSeniorContract workWork experience placementWorldwideFlexible hours
- ...Job Summary The Senior Regulatory Affairs Program Specialist is responsible for leading... ...Review global regulatory submissions for technical accuracy and... ...Experience interacting with FDA and/or other regulatory... ...position is filled. For fully remote positions, compensation...Remote workSeniorMinimum wageOngoing contractLocal areaWorldwide
$110.2k - $176.4k
...support to internal stakeholders regarding regulatory requirements and compliance issues.... ...assurance, and engineering to ensure timely submission of applications and smooth approval... ...importance of flexibility and work-life balance. Remote or field-based positions will have...Remote workSeniorWork experience placementWork at office$70k - $92.5k
...Job Description Location: Remote with requirement to travel... ...business needs Role Purpose The Senior Associate, Regulatory Affairs is responsible for... ...guidance, managing submissions, and partnering cross-functionally... ...for compliance with FDA, USDA, FTC, and international...Remote workSeniorFixed term contractWork at officeLocal areaFlexible hours$115k - $185k
...Senior Regulatory Affairs Specialist (Senior IC or Manager) Lexington Medical, Inc. is hiring... ...global medical device submissions and regulatory strategy. For... ...area, this role can be remote with expectations to work... ..., and guidance, including FDA requirements, EU MDR, MDSAP...Remote workSeniorFull timeLocal areaFlexible hours- ...Senior Regulatory Specialist Location: Philadelphia, PA Rate: $55/Hr on C2C... ...We need strong profiles with 510(k) submission experience for SaMD products. Medical... ...years working in a regulated industry (FDA and Software as a Medical Device preferred...Senior
$110.2k - $176.4k
...support to internal stakeholders regarding regulatory requirements and compliance issues.... ...assurance, and engineering to ensure timely submission of applications and smooth approval... ...importance of flexibility and work-life balance. Remote or field-based positions will have...Remote workSeniorHourly payDaily paidTemporary workWork experience placementWork at officeFlexible hoursShift work- ...Research Compliance Specialist Senior The Michigan Institute... ...monitoring and regulatory compliance support for... ...initiated, single-site FDA-regulated studies. This... ...conduct on-site and remote monitoring visits,... ...Critically review submission documents and clinical...Remote workSeniorWork experience placementInterim roleLocal area
- ...Overview Regulatory Affairs Consultant - China (IVD / IUO / Software) Location: U.S.-based (remote) Engagement: Contract / Consulting (scope and duration TBD) We are supporting... ...planning for potential future NMPA submissions , as applicable Required Experience & Qualifications...Remote workContract work
- ZEISS Meditec Inc. is seeking a Senior Advisor for Regulatory and Clinical Affairs to manage FDA submission strategies and guide clinical research for ophthalmic devices. This role entails overseeing regulatory processes for product commercialization and collaborating across...Remote jobSenior
$75k - $85k
A regulatory affairs organization in Bethesda is seeking a Regulatory Specialist to manage regulatory submissions and scientific document preparations. The role requires a Bachelor's Degree... ...offers 2 days on-site and 3 days remote work. The salary ranges from $75,000...Remote workWork at office- ...A leading biopharmaceutical company is looking for a Senior Medical Writer to develop clinical documents for regulatory submissions. The candidate will manage medical writing projects, lead timelines, and collaborate with cross-functional teams. Key qualifications include...Remote workSenior
- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ..., stock incentives, and generous PTO. This position offers a remote work option with travel as needed. #J-18808-Ljbffr...Remote workSenior
- ...A leading healthcare company in Eagan, Minnesota is seeking a Senior Submissions Healthcare Data Analyst to perform data analysis, quality assurance, and regulatory submissions focused on Risk Adjustment and Medicare Advantage data. Candidates must have extensive experience...Remote workSenior
$110k - $222k
...for this position. The Role As a Senior Consultant in Workplace Consulting (... ...goals under overarching ERISA or other regulatory requirements. This includes facilitating... ...Experience with IRS/DOL correction programs and submissions ~ Outstanding partnership skills and...Remote workSeniorWork from home$128k - $176k
...leading biotech company is looking for a Senior Medical Writer to provide support for developing complex clinical and regulatory documents. The ideal candidate will have a... ...authoring and managing content for regulatory submissions and ensuring quality standards are met....Remote workSenior- ...Senior Regulatory Reporting Analyst Location: Johnston, RI (Remote) Contract JD 5–10+ years of experience in regulatory reporting, risk reporting, or banking... .... Prior experience supporting live regulatory submissions is mandatory. Strong experience in US Banking...Remote workSeniorContract work
- ...Regulatory Solutions Specialist Lumelight is an integrated workplace administration... ...for the preparation, submission, and management of regulatory... ...consultant to join our team. The Senior Compliance Consultant... .... This is a remote position with occasional travel...Remote workSeniorWork at officeFlexible hours
- ...risks and challenges. In depth knowledge of relevant security regulatory compliance requirements and translating those into business... ...evidence. Ensure that all documentation is properly prepared for submission to eMASS if the organization is seeking certification....Remote workSenior
- ...Position: Sr. Regulatory Affairs Specialist Location: Tempe, AZ Duration: 1... ..., position would start as remote; however once these restrictions... ...The Regulatory Affairs Senior Specialist is responsible... ...preparation of regulatory submissions required to legally market...Remote workSeniorContract workPart timeH1bLocal areaFlexible hoursDay shift
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