Remote SVP, Clinical Affairs — Device & Drug Leader
NEXT Life Sciences, Inc.
- Remote job
NEXT Life Sciences, Inc. seeks a Senior Vice President, Clinical Affairs to own clinical strategy and execution across its portfolio of medical devices and pharmaceutical products. The SVP leads the clinical operations team, designs pivotal studies, and drives regulatory submissions from design through FDA approvals. The candidate will oversee CROs and budgets, manage safety reporting, and coordinate with the CEO, Board, and investors. #J-18808-Ljbffr NEXT Life Sciences, Inc.
- ...seeking a Senior Regulatory Affairs Specialist to lead regulatory... ...coordinate with product development, clinical, and quality assurance to... ...experience in medical device regulatory submissions (510(k... ...audits (ISO 13485, MDSAP), with remote/work-from-home flexibility #J...Remote jobWork from home
- ...Associates, Inc. is seeking a Regulatory Affairs Leader for the Aortic Business Group. This remote role develops global regulatory... ...marketing approvals for medical devices, including PMA products. You... ...Associates, collaborate with Clinical, Product, and Technical teams,...Remote job
- Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME - Drugs, Biologics & Medical Devices for an onsite role in Fort Detrick, MD. You will lead regulatory strategies, submissions, and agency interactions to support military, DoD, and commercial programs. Responsibilities...Suggested
$290k - $350k
...Director, Global Medical Affairs Lead - Oncology Reports to: SVP, Head of Clinical Development and Medical Affairs Location: Remote Position Overview:... ...relationships with key opinion leaders, healthcare... ...(medical, prescription drugs, dental, and vision insurance...Remote work- .... Arcetyp LLC is looking for a Senior DoD Regulatory Affairs SME - Drugs, Biologics & Medical Devices. This position is onsite and located in Fort Detrick,... ...Prepare/review INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting packages, audit reports...Remote workFull timeH1b
$192.4k - $302.39k
...The Global Medical Affairs Lead, PDT... ...Medical Affairs, clinical, regulatory, safety... ...digital technologies, device innovation, and technology... ...with key opinion leaders and other external... ...multidisciplinary drug development... ...Takeda's Hybrid and Remote Work policy. Takeda...Remote workMinimum wageFull timeLocal areaWorldwideWeekend work- Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities... ...Restorative Healing Technologies portfolio. Remote work is available in the United States... ...record in regulatory affairs within medical devices, plus experience with ISO 13485, MDSAP,...Remote job
- MiniMed, a global leader in diabetes care, seeks a Principal Regulatory Affairs Specialist to guide medical devices and software through US FDA, EU MDR, and other global pathways.... ..., EU, and international teams. This 100% remote role offers collaboration across functions...Remote job
- ...Praxis Precision Medicines, Inc. seeks a Program Leader to drive a drug-device combination program from design through regulatory submission. You... ...executive leadership with urgency and rigor. This role requires remote work with occasional travel. #J-18808-Ljbffr Jobleads-...Remote work
- ...partner is looking for a Manager, Clinical Affairs based in the United States.... ...for an innovative medical device platform focused on treating... ...working with the U.S. Food and Drug Administration (FDA) and/or... ...Full-time employment. Remote working arrangement, with the...Remote workFull time
- Scorpion Therapeutics is seeking a Principal Scientist for CMC Regulatory Affairs focused on combination products. The role involves shaping regulatory strategy across clinical, marketing, and lifecycle activities, preparing submission content, and supporting health authority...
$178k - $222.5k
...Terumo is a global leader in medical technology,... ...enterprise-wide government affairs capability to ensure a... ...stakeholders. LOCATION: U.S. Remote, D.C. Preferred JOB... .... We manufacture devices, disposable sets and... ...workplaces, and we maintain a drug‑free workplace and...Remote workWork at officeShift work$120k - $140k
...develops innovative medical devices used to diagnose and treat coronary... ...includes a broad range of clinically relevant products, such as... ...Catheters; the Orsiro™ Mission™ Drug-Eluting Stent; the PK Papyrus... ...Summary The Clinical Affairs Manager will provide clinical...Remote workFull timeTemporary workWork at officeLocal areaFlexible hoursNight shift$325.6k
...patients. The Medical Affairs and Evidence Generation... ...profile development, clinical development plans, and... ...commercial. This strategic leader serves in a “player... ...trials Knowledge of drug development and an existing... ...Job location: US (remote okay) #LI-remote ...Remote workFull timeTemporary workWork at office- Emmes is seeking a Manager, Regulatory Affairs to lead regulatory strategy for multiple clinical development programs. The role combines advisory leadership with... ...approval pathways. Based in the United States with remote work options, you will manage a team of Regulatory...Remote job
- Solventum, a health care innovator, seeks a Senior Regulatory Affairs Specialist to lead a team supporting Restorative Healing Technologies... ..., and coordinating with internal and contract partners to meet milestones. Remote US work available. #J-18808-Ljbffr SOLVENTUMRemote jobContract work
- ...Executive Director, Global Medical Affairs Lead, Oncology About the... ...This pivotal role demands a leader with a strong background in... .... The position is remote and may require up to 20% travel... ...Hiring Manager Title SVP, Head of Clinical Development and Medical Affairs...Remote work
$140k - $180k
All Jobs > Senior Manager, Clinical Quality Assurance (Remote) Senior Manager, Clinical Quality Assurance (Remote) United States Description The Senior... ...trial are conducted properly Prepare and manage the Drug Development Quality Management Plan including risk management...Remote jobWork at office- ...X and YouTube. The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation... ...on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial....
$205k - $225k
...Praxis Precision Medicines, Inc. seeks a Program Leader to drive a drug-device combination program, bridging drug development and device engineering... ...with strategic leadership across regulatory, quality, clinical, and operations to move the program toward the clinic....Remote job- ...Program Management to lead cross-functional drug development programs from strategy to execution. You will partner with clinical, regulatory, CMC, nonclinical, commercial and... ...in South San Francisco on Wednesdays and Thursdays; remote staff #J-18808-Ljbffr Jobleads-USRemote work
$189.5k - $235k
...Name Director, Regulatory Affairs-Global Regulatory Lead... ..., PA, Oxford, UK, Remote, US Department Regulatory... ...Overseeing regulatory review of clinical trial labelling and CMC... ...Solid track record in drug development and... ...autoimmune disease. Our leaders in R&D are internationally...Remote workFull timeWork at officeLocal areaWorldwideNight shift$123.46k - $169.75k
...ensures alignment between product strategy, clinical value proposition, and commercial... ...experience in healthcare technology, medical devices, or oncology preferred ~ Proven track record... ...in more than 70 countries. As a leader in medical technology, we constantly push...Remote workFull timeTemporary workWork at officeLocal areaShift work- Colgate-Palmolive is seeking a Regulatory Affairs Project Manager in Piscataway, NJ, to lead global regulatory submissions for medical devices and Rx drug portfolios while maintaining QMS compliance. You will drive cross-functional collaboration, manage ISO/FDA requirements...Relocation package
$140k - $190k
Drug Use Policy Manager- Southern California Posted 19 days ago $140k - $190k/yr Permanent Southern California, California Quick Facts Strong Clinical Focus Competitive Compensation Top Ranked Hospital Description An excellent Drug Use Policy Manager opportunity is available...Permanent employmentFull timeContract workRelocation packageMonday to FridayWeekend work$79.3k - $118.9k
...diabetes. We’re seeking a Clinical Product Specialist to... ...Development, Medical Affairs, Marketing, Research &... ...position is eligible for 100% remote working arrangements (... ...an innovative medical device company dedicated to... ...non-insulin subcutaneous drugs across other...Remote workFull timeWork from homeFlexible hours- Philips in Cambridge, MA is seeking a Senior Regulatory Affairs Specialist to drive regulatory initiatives for CT/AMI hardware. You will... ...EU, and other markets. You will collaborate with R&D, Quality, Clinical, and Manufacturing to ensure regulatory requirements are...
- Werfen is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory and quality system support for U.S., Canada, and... ...product lines. You will coordinate submissions (510(k), BLA, and device licenses) and maintain technical documentation, ensuring...
- ...Clinical Trial Investigator Serve as main CTI contact... ...Manager. Conduct remote monitoring and complete... ...support to Regulatory Affairs Study Start-up Team in... ...lifecycle of development, from drug concept to... ...biotechnology, and medical device firms. For more information...Remote workContract workInterim roleWork from home
- Werfen is seeking a Senior Principal Regulatory Affairs Specialist to support regulatory affairs and quality systems for US, Canada, and... ...requirements. The ideal candidate has 8+ years in medical device regulatory affairs, with strong knowledge of FDA and EU regulations...
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