Remote Regulatory Biomedical Engineer — FDA Submissions
Tunnell Government Services, Inc.
- Remote job
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 Tunnell Government Services, Inc.
$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- ...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 jobRegulatoryFlexible hours
- ...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 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
- ...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
- ...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 jobRegulatory
$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- 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
- 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
$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$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- ...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 jobRegulatory
- ...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 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 jobRegulatoryFlexible hours
- 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
- 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 Praxis...Remote jobRegulatory
- ...Regulatory Submission Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion...Remote workRegulatoryLocal area
$70k - $130k
Tonix Pharmaceuticals is seeking a Senior Specialist, Regulatory Operations to manage submission processes across the development pipeline. This role requires... ..., dental, and retirement options. Flexibility to work remotely is also available. #J-18808-Ljbffr Tonix...Remote jobRegulatory$70k - $130k
...biotechnology company is seeking a Senior Specialist in Regulatory Operations to manage regulatory submissions across their development pipeline. The role involves... ...s degree in a scientific field. The position can be remote or based at the company's office in New Jersey,...Remote jobRegulatoryWork at office- ...development of high-quality clinical and regulatory documents across the drug lifecycle. The... ...efficiency Ensure accurate, consistent, submission-ready documentation Support regulatory... ...projects and meet tight deadlines This role is remote in the US, East Coast strongly preferred...Remote jobRegulatory
- ...matters, your journey starts here!/ppThe Biomedical Engineering (BME) Department at Carnegie Mellon... ...compliance with institutional, federal, and regulatory standards. The technician will work... ...required to travel to off?campus or remote study locations./li/ul/ulpJoining the...Remote workRegulatoryHourly payFull timePart timeFixed term contractWork experience placementNight shift
$50k - $200k
...Description Job Description At CP Engineers, we recognize that there is... ...our team. We will review submissions on an individual basis, and... ...scopes, budgets, schedules, regulatory coordination, and client... .... Benefits ~ Remote work flexibility ~ Schedule...Remote workRegulatoryHourly payFull timeWork at officeImmediate startFlexible hours- ...Principal Statistician Oncology With Submission Experience Syneos Health® is a leading... ...submissions, integrated analyses), and attend regulatory agency meetings or responds to questions... ..., we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized...Remote workRegulatory
- Associate Director, Case Management Intake & Submissions Overview Responsible for oversight of... .... This hybrid role combines on‑site and remote work. Responsibilities Oversee intake... ...compliance with country‑specific regulatory and business requirements related to expedited...Remote workRegulatoryLocal area
- Sr. Biomedical Engineer - Device job at Merz North America. Caledonia, WI.... ..., design requirements, and regulatory standards. Collaboration Work... ...and standards (e.g., FDA, CE Mark, IEC 60601 series,... ...policies. Support regulatory submissions. Leadership Mentor junior electrical...Regulatory
- Summary The Biomedical Engineer reports to Healthcare Technology Management within the Clinical... ...systems, and ensures compliance with regulatory and safety standards. Duties Act as a... ...Completion of an online onboarding process and submission of acceptable identification....RegulatoryContract workFor contractorsSeasonal workTrial periodMonday to Friday
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