Remote Regulatory Biomedical Engineer FDA Submissions
Tunnell Government Services, Inc.
Tunnell Government Services, Inc. is looking for a skilled professional to support analyses of medical devices in Bethesda, Maryland. This role involves coordinating with stakeholders, writing detailed documents, and providing consultation for regulatory submissions related to biomedical engineering. The ideal candidate must possess a bachelor’s degree in biomedical engineering with a preference for those having 10 years of experience and an advanced degree. This position allows for 100% telework, making it flexible for qualified applicants. #J-18808-Ljbffr
- ...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... ...shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing...Remote workRegulatoryFlexible hours
$100k - $140k
...Salary: Job Title: Sr Biomedical Engineer with Electrical and... ...performance and regulatory requirements. Key... ...) in compliance with FDA 21 CFR 820 and applicable... ...standards for 510(k) submissions Develop and manage... ...adequately from a remote location Must be authorized...Remote workRegulatoryBi-weekly payFull timeWorldwide- ...Crossing Hurdles is seeking a Regulatory Medical Writer for FDA submissions. This remote role involves developing structured prompts, authoring regulatory documentation, and ensuring compliance with FDA guidelines. The ideal candidate has extensive experience with FDA...Remote workRegulatory
- ...entirely in-house from concept through FDA submission. If you are motivated by hard... ...We have openings for Mechanical or Biomedical Engineers who are either recent graduates or have... ...Contribute to risk analysis, labeling, and regulatory documentation Requirements What...Regulatory
- ...is seeking a Patient Safety Expertise Biomedical Engineer to support a comprehensive Healthcare... ...involves managing medical device safety, regulatory compliance, and conducting... ...ensure safety. The position is primarily remote with up to 30 short-duration trips annually...Remote workRegulatory
- ...include initiating, monitoring, and closing studies, preparing regulatory submissions, and supporting contracting processes. Required... ...The role offers an attractive salary and a supportive team environment, with remote working options available. #J-18808-Ljbffr...Remote workRegulatory
- ...Associate Director/Director of Regulatory Affairs to oversee regulatory strategies and manage submissions for pharmaceutical products.... ...strong leadership in navigating FDA requirements, excellent... ...particularly with ANDA submissions. This remote position is ideal for...Remote workRegulatory
- ...is seeking a Senior Algorithms Engineer to develop and optimize algorithms for remote health monitoring systems. The ideal... ...have a strong background in biomedical signal processing and experience... ...technical partnership with clinical and regulatory teams. A Bachelor's degree and...Remote workRegulatory
$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory... ...medication approved by both the FDA and European Commission for the... ...arrangements, including hybrid and remote options.Madrigal’s Total Rewards strategy...Remote workRegulatoryMinimum wageFull timeLocal areaFlexible hours- ...an innovative and motivated Biomedical Engineer to join our dedicated engineering... ...ensuring compliance with regulatory standards. You will... ...development. This position may be remote with travel as needed by the... ...standards. Ensure compliance with FDA regulations and industry...Remote workRegulatory
- ...seeking a highly skilled Pharma Submissions Specialist to manage the... ...will ensure compliance with regulatory requirements and timely submissions... ...position offers flexible remote work within the US and is ideal for those experienced in FDA regulations and who can work...Remote workRegulatoryTemporary workFlexible hoursAfternoon shift
$95k - $125k
...Project Manager - Biomedical Engineering Fully Remote - Based in USA About Blue Water Thinking Guided by our principles of value generation, continuous... ...health care facilities. Understanding of federal regulatory requirements, including those from The Joint Commission...Remote workRegulatoryLocal area- Summary As a Supervisory Biomedical Engineer for VA Palo Alto Health Care System (VAPAHCS), this... ...Joint Commission—NFPA and other pertinent regulatory requirements. The incumbent provides... ..., remediation, patching, and secure remote connectivity of networked medical...Remote workRegulatoryPermanent employmentWork at officeLocal areaRelocation packageMonday to Friday
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading regulatory... ...strategies for drug approvals and submissions. Candidates should have extensive... ...submissions. The position is hybrid, with remote work and occasional onsite requirements,...Remote jobRegulatory$90k - $220k
...Scientific and Technical Advisor: Biomedical Engineering At Intertwine Associates, we live by a... ...IARPA Ability to synthesize technical, regulatory, and clinical considerations into... ...role is: 90,000 - 220,000 USD per year (Remote (United States)) #J-18808-LjbffrRemote workRegulatoryContract workLocal area- The Fountain Group is seeking a Sr. Regulatory Affairs Specialist for a prominent client. This position is remote and involves preparing regulatory submissions, leading projects, and ensuring compliance with global standards. The role requires a Bachelor's degree in a relevant...Remote jobRegulatory
- ...leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves... ...in the US and Europe. This is a remote position requiring expertise in compliance...Remote workRegulatory
$130k - $160k
...overseeing the medical writing team and ensuring high-quality regulatory documents for market submissions. The role includes mentoring writers, managing... ...diagnostics or pharmaceutical sector. The position is fully remote, offering a compensation range of $130-160k with...Remote jobRegulatory$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 workRegulatoryWork at office$186.4k - $233k
...include team leadership, oversight of programming functions, regulatory submissions, and ensuring data integrity. Candidates must have a minimum... ...in R, and a proven track record of team development. This remote position offers a competitive compensation range from $186,4...Remote workRegulatory- ...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 workRegulatory
- ...seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will have an... ...significant medical writing experience, particularly in regulatory submissions. This role offers a competitive salary and a variety of...Remote workRegulatoryFlexible hours
$221k - $286k
...Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide global... ...includes overseeing global CMC strategies, submissions, and managing workforce talent.... ...benefits. This position offers flexible work with remote options. #J-18808-Ljbffr Kite PharmaRemote workRegulatoryFlexible hours- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...match, stock incentives, and generous PTO. This position offers a remote work option with travel as needed. #J-18808-Ljbffr...Remote workRegulatory
- ...Wehavebelowurgentlongtermcontractprojectimmediatelyavailable for******Business Analyst Mid Level, Remote work****** need submissions you please review the below role, if you are available,... ...Experience with control definition or operation to meet regulatory objectives (PCI, SOX, GDPR, GxP)**SKILLS:** "Business...Remote workRegulatoryPermanent employmentContract workFor contractorsImmediate startRelocationDay shift
- A biotechnology company is seeking a Senior Specialist for Regulatory Operations to manage regulatory submissions and support systems in Frederick, MD. This role requires 3-4 years of relevant experience in the biotech or pharmaceutical industry, along with a strong understanding...Remote jobRegulatory
- ...seeking a highly experienced Regulatory Consultant with deep... ...regulatory strategy and submissions. This role is remote. Job Duties Work... ...processes in compliance with FDA regulations. Develop,... ...university in science, biomedical engineering, plus a minimum of 10...Remote workRegulatoryLocal area
- Randstad USA is seeking a seasoned professional for a 100% remote contract role to lead end-to-end planning and execution for major... ...or related fields, along with 8+ years of experience in regulatory submissions management, and will coordinate cross-functional teams effectively...Remote jobRegulatoryContract work
- ...the Wallace H. Coulter Department of Biomedical Engineering at Emory University, within the School... ...contributes to manuscripts, grant reports, and regulatory documentation. Prepares shipments of... ...an Emory University location; working remote is not an option. Emory reserves the...Remote workRegulatoryWork experience placementInternship
$100.71k - $110.42k
Job Summary The Regulatory Specialist reports to the Senior Manager,... ...filing of high-quality regulatory submissions and for post-approval... ...per week and 2 days per week remote. Requirements Must have a Bachelor... ...and Annual Reports to FDA; demonstrated expertise successfully...Remote jobRegulatoryWork at office2 days per week3 days per week
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