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
$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$50 - $67 per hour
...0.00/hr - $67.00/hr Sr. Regulatory Specialist Fully remote in PST time zone ONLY Do... ...is a key contributor to FDA submissions (PMA/510(k)) and requires... ...scientific writing, knowledge of IVD product development... ...documentation. Seniority level Mid‑Senior level Employment...Remote workSeniorContract work$106k - $170.2k
...Senior Regulatory Affairs Specialist Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...in the Santa Clara office (no remote option). The role provides... ...regulatory documentation for submissions to European Notified Bodies, FDA, and other authorities, and...Remote workSeniorWork at officeLocal areaImmediate startFlexible hours$105.8k - $132.25k
...A global healthcare company is seeking a Regulatory Affairs Specialist III in San Diego, CA. This role focuses on ensuring regulatory compliance and global market access for in-vitro diagnostic (IVD) products. Candidates must have a Bachelor’s degree and at least 6 years...Senior$80 - $100 per hour
...00.00/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... ...full‑time) Location: Remote with some travel to... ...submissions to FDA Collaborating with...Remote workSeniorHourly payPermanent employmentFull timeContract workFor contractors- 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
$80k - $140k
...diseases. Unified Care specialists support patients at... ...doctor’s appointments with remote patient monitoring (... ...will be part of the regulatory team responsible for proper... ...an ISO 13485 and FDA compliant Quality Management... ...review of regulatory submissions to the US FDA and...Remote workSeniorFull timeWork experience placement$92.7k - $152.9k
Senior International Regulatory Affairs Specialist - BD (Milpitas, CA) We are seeking a Senior International... ...in vitro diagnostic (IVD) devices, including... ...and managing regulatory submissions worldwide. Key... ...presence per week is required. Remote or field‑based arrangements...Remote workSeniorWork at officeLocal areaWorldwide- ...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
- BeiGene, Ltd. is looking for a Senior Associate to manage U.S. regulatory submissions including INDs, NDAs, and BLAs. The role requires excellent communication, organizational skills, and a proactive approach. Experienced professionals with a scientific background and...Senior
$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- 6AM City, LLC is seeking a Regulatory Operations Contractor to support the development and implementation of systems for regulatory submission activities. This position offers fully remote work options and requires candidates to work during EST hours. Responsibilities include...Remote workContract workFor contractors
$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$85k - $95k
...LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations and regulatory submissions for active implantable medical devices. The role entails preparing evaluation plans, managing submissions, and collaborating across teams to ensure compliance...Remote workFlexible hours- 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
$100.71k - $110.42k
...Job Summary The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The... ...high-quality regulatory submissions and for post-approval maintenance... ...week and 2 days per week remote. Requirements Must have a... ...and Annual Reports to FDA; demonstrated expertise...Remote workWork at office2 days per week3 days per week- ...biotechnology company is seeking a seasoned Regulatory Affairs Consultant to shape... ...role involves preparing for IND/IMPD submissions and leading FDA/EMA interactions. Candidates should have... ...a dynamic start-up environment. This remote-friendly position offers the potential...Remote workSenior
$110k - $135k
...Integrated DNA Technologies is seeking a Regulatory Affairs professional to lead the creation of regulatory documents and ensure compliance with FDA and EU regulations. Located in Boulder, CO, this fully remote role requires a Bachelor's degree in a technical field and...Remote workSenior- ...SENSAPURE INC is looking for an experienced Sr. Regulatory Specialist to manage raw material specifications and ensure compliance with regulations. This role entails overseeing the creation of specifications, maintaining records, and collaborating with suppliers. Candidates...Remote workSeniorFull time
- ...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
$54.4k - $111.5k
...Fifth Third Bank is seeking a Principal Review Specialist in Cincinnati, Ohio, to oversee brokerage and insurance sales supervision. Responsibilities include ensuring compliance with regulations, evaluating the appropriateness of transactions, and mitigating risks. Ideal...Remote workSenior- ...university in New Haven is looking for a Senior Analyst for the Human Research... .... This role involves reviewing research submissions, ensuring compliance with ethical standards... ...related fields. This position offers flexible remote work options and a commitment to diversity...Remote workSeniorFlexible hours
- ...Trilogy Writing & Consulting is looking for a Senior Quality Control Specialist (f/m/d) to oversee quality control for regulatory documents in the international pharmaceutical industry. This role can be onsite or remote. Qualified applicants must have at least 3 years...Remote workSenior
- ...Crown-Castle is seeking a Sr Regulatory Specialist, Environmental Compliance in Canonsburg, PA. This role is integral to ensuring compliance... ...roles. The position offers a hybrid work model, allowing 2 days remote work per week and extensive benefits, including a...Remote workSenior2 days per week
$120k - $150k
Danaher Corporation is looking for a Senior Clinical Study Manager to oversee clinical... ...for Radiometer Medical in a fully remote role. The ideal candidate will have extensive regulatory expertise and operational oversight skills in IVD/MD clinical studies. Responsibilities...Remote jobSenior$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$110k - $135k
Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance within life sciences and diagnostics... ...in in vitro diagnostics. This position is fully remote, offers a salary range of $110,000 - $135,000, and...Remote jobSenior- ...ZEISS Meditec Inc. is looking for a Senior Advisor in Regulatory and Clinical Affairs to direct regulatory and clinical strategies... ...This role requires 15 years of experience in an FDA-regulated environment, guiding submissions and overseeing clinical research. The ideal...Remote workSenior
- ...Conagra Brands is seeking an experienced professional in Food Safety and Quality to support operational quality assessments and regulatory affairs. The role involves significant communication and collaboration with facility leadership teams and compliance with food safety...Remote workSenior
$95.26k - $157.21k
...Certification and other related external regulatory, accreditation and certification... ...of corrective action plan with hospital senior leaders. Maintain the collection and analysis... ...tracer auditing database. Eligible for remote work permitted up to 1 day per week. EDUCATION...Remote workSeniorShift work1 day per week
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