Senior Director, Clinical Affairs - IDE Trial Lead
Supira Medical, Inc.
Supira Medical, Inc. is seeking a Senior Director of Clinical Affairs to lead the IDE pivotal trial for a new pVAD therapy. You will own cross-functional execution from site activation through database lock, ensuring on-time, on-budget delivery with data integrity for PMA readiness. You will oversee protocol design, regulatory compliance (FDA/ISO 14155), CRO/vendor management, and KOL engagement, while collaborating with R&D, Regulatory, Quality, and Marketing to align clinical strategy with #J-18808-Ljbffr Supira Medical, Inc.
- Shifamed LLC is seeking a Sr. Clinical Trial Manager to own end-to-end execution of clinical studies across IDE pivotal trials, registries, and international... ...execution. Reporting to the Sr. Director of Clinical Affairs, you will lead start-up through closeout, ensuring...Senior
$200k - $230k
Supira Medical, a clinical-stage Shifamed Portfolio Company... .... Description: The Senior Director, Clinical Affairs is a hands-on leadership... ...success of Supira Medical's IDE pivotal clinical trial. This individual will... ...informed consent documents; lead content and completion...SeniorFull timeTemporary workFor contractorsWork experience placement- ...Johnson & Johnson seeks a Senior Regulatory Affairs Program Lead to develop and execute regulatory strategies for OTTAVA robotic surgical systems. The... ...write, and file FDA submissions including Q-submissions, IDEs, De Novos, and 510(k)s Serve as regulatory subject matter...Senior
- ...Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...for the best talent for a Senior Regulatory Affairs Program Lead to support our OTTAVA... ...engineering and clinical teams, supporting product... ...submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s). Lead FDA...SeniorRemote workFlexible hours
- ...DescriptionPrimary Function of PositionThe Director, Clinical Affairs- Endoluminal will guide,... ...execute long range clinical trial strategies, inclusive of... ...and ResponsibilitiesPlay a lead role in the development of... ...(first human use and/or IDE studies), post-market evidence...SuggestedLocal areaWorldwideFlexible hours
- Intuitive seeks a Lead Biostatistician to define the statistical vision for clinical studies from early feasibility to post-market evidence generation. You will lead... ...and drive a data-driven culture across Clinical Affairs, delivering high-impact analyses and insights....Senior
- Payactiv is a FinTech company focused on Earned Wage Access, helping workers access their wages. We seek a Director of State Government Affairs to lead nationwide state legislative and regulatory strategy, building bipartisan relationships and coordinating campaigns. The...SeniorRemote job
- Global Technical Talent is seeking a Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across international markets. The role focuses on assessing regulatory changes, coordinating impact assessments, and ensuring...SeniorContract work
$150k - $180k
...Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing... ...US, EU and Japan Regulatory Affairs activities for a class III,... ...regulatory submissions including US IDE, PMA, EU Design Dossiers and... ...knowledge of clinical trial strategy, study design and sponsor...Full timeTemporary workWork experience placementWork at office$140k - $180k
...company recently received US IDE approval for its QUADRA-... ...products to address clinical needs in the rapidly evolving... ...: The Sr. Clinical Trial Manager (Sr. CTM) is a hands... .... Reporting to the Sr. Director of Clinical Affairs, the Sr. CTM leads studies from start up through...SeniorFull timeContract workWork experience placementLocal area$161.5k - $242.3k
...generation strategy and execution of clinical studies. The Clinical Study... ...As a member of the Clinical Affairs team, this role will be... ...associates (CRAs), clinical trial assistants (CTAs) and data management... ...Job Duties Accountable for leading assigned clinical research...SeniorInterim roleWork at officeLocal areaRemote workWorldwideFlexible hoursShift work- Eridu is seeking a hands-on ASIC Design Verification Lead to own verification strategy, infrastructure, and closure for high-performance networking silicon. This senior role requires deep expertise and practical hands-on work beyond management in a fast-moving startup....Senior
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Santa Clara, CA. This role leads regulatory... ...devices. You will collaborate with engineering and clinical teams to generate submission-ready documentation, manage...SeniorRemote job
$160k - $190k
....We are currently seeking a Senior Regulatory Affairs Manager to join our team. This... ..., sustaining, and clinical study projects and related submissions... ...of effective clinical trial strategies.Manages and prepares... ...Notices, Annual Reports and IDE submissions).Reviews and approves...SeniorWork at office2 days per week3 days per week- ...Intuitive Surgical in Sunnyvale, CA, seeks a Sr. Regulatory Affairs professional to lead regulatory strategies across product lifecycle for robotic-assisted surgery devices. You will develop regulatory plans, review design controls, and coordinate submissions with FDA...
- Charles Schwab in California is seeking a Sr. Manager, Wealth Advisor to enhance client relationships through holistic financial planning and personalized investment guidance. This role requires strong leadership in managing client needs and delivering solutions that align...Senior
- ...Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager Abbott is a global healthcare... ...of healthcare, with leading businesses and products in... ...product performance, medical affairs, Clinical R&D, Quality... ...Performs proactive clinical trial signal detection (planning...SeniorWork experience placement
$130.7k - $261.3k
...spectrum of healthcare, with leading businesses and products in... ...We are recruiting for a Senior Regulatory Affairs Manager to join our Digital... ...teams on product development, clinical evaluation, manufacturing... ...products.Authoring PMA and/or IDE supplements, Pre-...SeniorWork experience placementWorldwideShift work$182.36k - $273.2k
...beyond fleeting trends, Marvell is a place to thrive, learn, and lead. Your Team, Your ImpactMarvell’s Optical DSP (ODSP) team within... ...Pavia, Irvine, Vietnam, and Argentina — and we are looking for a senior experienced technical leader to serve as Hardware Chip Lead on...SeniorPermanent employmentFull timeWork from home- ...Waters seeks an Associate Director of Clinical Affairs to lead global clinical study operations for the Biosciences business. The role oversees clinical project execution, manages a team of clinical professionals, and ensures regulatory compliance and evidence generation...
- ...assignments, this role helps senior leaders connect product design, intended use, clinical workflow, risk... ...Advisory Leadership • Lead regulatory strategy across... ...investigations, including IDEs and related study... ...of related regulatory affairs experience with a bachelor...Local areaWorldwideFlexible hours
- ...emergencies. Competitive compensation and full benefits accompany the position. Responsibilities include supervising direct care, leading admissions and transfers, coordinating with staff, and ensuring regulatory readiness. Requires active CA RN license and BLS CPR; wound...SeniorPart timeShift work
- ...looking for a Principal Regulatory Affairs Associate to help drive... ...years as a principal, manager or lead. Significant experience in... ...submissions, 510(k)s, De Novos, and IDEs. Strong working knowledge... ...strategy interacts with clinical study design and algorithm performance...Full time
$183.8k - $294.1k
...transformative solutions that turn dreams into possibilities. Job Description The Associate Director, Clinical Affairs reports to the Senior Director, Medical Affairs and leads Clinical Affairs operations globally for the Waters Biosciences business. This individual is...Hourly payContract workWork at officeRemote workWorldwideShift work- ...Senior Regulatory Affairs SpecialistAt EBR Systems, Inc., we are not imagining that future—we are building it. We are the team behind the world's first FDA approved, leadless left ventricular endocardial pacing device for heart failure. It's a breakthrough redefining what...Senior
$224k - $356.5k
We at NVIDIA seek an Senior Developer Relations, Automated Synthetic Chemistry Science Lead who can coordinate science streams.This role exists at the crossroads of experimental science, optimization, analytical characterization, AI modeling, laboratory automation, and...SeniorFull time- Retrotope, Inc. in Mountain View, California is seeking a Clinical Research Associate to manage clinical trial coordination for various studies. This role involves ensuring compliance with study protocols, overseeing timelines, and acting as the main point of contact for...Senior
$224k - $356.5k
...Convert scientific therapeutic objectives into executable plans.Lead NVIDIA workstreams spanning data curation & analysis, machine learning... ...and involvement with advancing RNA therapeutics from pre-clinical to clinical phases (e.g. siRNAs, ASOs, mRNA vaccines).Prior leadership...SeniorFull time- ...Etched is seeking an SMT Line Lead to run its in-house SMT line, from incoming material to finished modules. You will build and lead the line's operations team and partner with process engineering, equipment, and procurement to deliver high-yield, on-spec assemblies for...SeniorShift work
$86.7k - $173.3k
...spectrum of healthcare, with leading businesses and products in diagnostics... ...Principal Regulatory Affairs Specialist to join our Vascular... ...Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply... ...0(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions. ~...For contractors
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