Director, Clinical Affairs - Neurovascular Medical Devices
Paylocity
Spryte Medical is seeking an experienced Director, Clinical Affairs to provide strategic and operational leadership for the company's clinical research activities. This role encompasses planning, execution, oversight, and continuous improvement of clinical studies supporting regulatory submissions and product development. The Director will ensure compliance with ICH-GCP, ISO 14155, and FDA regulations, collaborate with Regulatory Affairs, Quality, R&D, and Biostatistics, and build the Clinical #J-18808-Ljbffr Paylocity
$215k - $230k
...Description About Spryte Medical At Spryte Medical, we're advancing the future of neurovascular care by developing breakthrough... ...and highly motivated Director, Clinical Affairs to provide strategic and operational... ...within the medical device industry. · Minimum 3 years...Medical deviceFull timeLocal area$171k - $273k
Job Title Director of Clinical Affairs - Ambulatory Monitoring and Diagnostics Job Description Director... ...role partners cross-functionally with Medical Affairs, R&D, Regulatory, Marketing,... ...management experience within the medical device industry, and 5+ years managing a...Medical deviceFull timeWork at officeRemote workWork visaRelocation package3 days per week- Senior Director, Clinical Development and Medical Affairs Cynosure Inc, 5 Carlisle Rd, Westford, Massachusetts, United States of America Job Description Cynosure... ...as the trusted scientific leader in energy-based devices. The ideal candidate combines deep scientific...Medical device
$215k - $230k
...Description About Spryte Medical At Spryte Medical... ...the future of neurovascular care by developing... ...experienced and strategic Director of Regulatory Affairs to lead the... ...innovative medical device portfolio. This individual... ...development, clinical programs, commercialization...Medical deviceFor contractorsLocal area- ...seeking a skilled and self-motivated Senior/Principal Regulatory Affairs Specialist to support the BrioVAD® Left Ventricular Assist... ...functional teams to support product development activities, US and EU clinical studies and regulatory planning and submission activities. You...Medical device
$115k - $130k
...-motivated Senior Regulatory Affairs Specialist to support the BrioVAD... ...activities, US and EU clinical studies and regulatory planning... ...with Clinical, R&D, Quality, Medical Affairs, and other cross-functional... ...communications, labeling, device changes, and other study-...Medical device$180k - $200k
...seasoned Market Regulatory Affairs Manager to lead and evolve our... ...in a high-volume IVD or medical device environment . You will lead... ...Regulatory Affairs Device Associate Director, Global Regulatory Affairs... ..., Regulatory Affairs (Clinical) Boston, MA $130,000.00-$180...Medical deviceFull timeContract workRemote work- ...day remote)Industry: Medical DeviceEmployment Type:... ...innovation-driven medical device company focused on... ...functionally with R&D, Clinical, and Operations to integrate... ...in regulatory affairs and quality assurance... ...$326,000.00 1 day ago Director/Senior Director, Corporate...Medical deviceFull timeRemote work
$171k - $273k
Job TitleClinical Affairs DirectorJob DescriptionClinical Affairs Director, Computed TomographyThe Clinical Affairs Director for Computed Tomography... ...of clinical and medical research insights into evidence... ...years of experience in medical devices (some experience required),...Medical deviceFull timeWork at officeImmediate startWork visa3 days per week- ...ophthalmic pharmaceutical and medical technology company focused on... ...by real science, robust clinical evidence, and an unrelenting... ...establishment registration and device listing submissionsSupport recurring... ...with other basic Regulatory Affairs functions, such as scanning...Medical deviceLocal area
- ...treatments that address serious unmet medical needs, including diabetes, pulmonary... ...disease. With deep expertise in drug-device combinations, MannKind aims to deliver... ...lives. Job Summary The Associate Director, Regulatory Affairs will be responsible for coordinating...Medical deviceFor contractorsWork at office
$200k - $245k
...,000.00 / Year Job Category Clinical Operations Required Degree 4... ...VP, Clinical Operations, the Director, Clinical Operations is... ...Development, Regulatory, Biometrics, Medical Affairs, Quality, and other... ...biotech, pharma, or medical device organizations, including management...Medical deviceTemporary workWork at officeLocal areaImmediate start3 days per week- ...functional teams to ensure compliant, timely filings for US and international markets. Required are 5-8 years in regulatory affairs for medical devices, strong knowledge of FDA/IVD regulations, and a proven ability to manage multiple priorities while meeting deadlines. #J...Medical device
- A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Medical device
- Philips is hiring a Regulatory Affairs leader in Cambridge, Massachusetts, focusing on strategic regulatory leadership for software-enabled medical devices. The role involves developing regulatory strategies, guiding new product introductions, and ensuring compliance with...Medical device
- Spryte Medical seeks a Director of Regulatory Affairs to guide global regulatory strategy for a portfolio of neurovascular imaging devices. You will lead cross‑functional teams, manage complex submissions, and oversee external regulators to accelerate market access. The...Medical device
$170k - $215k
...service across the biopharmaceutical and clinical markets. Job Summary: The Global... ...works with Product Management, Sales, Medical/Clinical Affairs, Sales Operations, and R&D through... ...product launches in diagnostics, medical devices, or healthcare technology. Demand...Medical deviceHourly payWork at officeFlexible hoursShift work- ..., NJ / Cambridge, MA is seeking a Senior Manager, Regulatory Affairs Advertising and Promotion to lead independent review of advertising... ...role requires a life sciences degree and 3+ years in pharma/medical device ad and promo review, with strong cross-functional #J-18808-...Medical device
- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance...Medical deviceRemote job
- Meridian Bioscience International Limited is seeking a Regulatory Affairs professional to support released products, including MDR... ...related field and at least four years of regulatory experience in medical devices/pharma. #J-18808-Ljbffr Meridian Bioscience International...Medical device
- ...TitleResponsibilities:Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare... ...EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation. Plan and prepare submissions for EU Class...Medical deviceWorldwide
- Philips in Cambridge, MA seeks a Director of Clinical Affairs for Ambulatory Monitoring and Diagnostics to lead clinical evidence programs and regulatory... ..., global regulatory knowledge, and collaboration with Medical Affairs, R&D, and commercial teams. Travel ~20-30% is...
- Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since... ...will be part of the Global Regulatory Affairs team and assists with planning, writing... ...documents (for products in phase 1-3 clinical development), labeling updates for marketed...Medical device
- Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies... ...and lifecycle management of Class II medical devices. Provide regulatory guidance during... ...& Development, Quality Assurance, Clinical, Manufacturing, Supply Chain, and...Medical device
- ...Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring.... ...level Seniority level Director Employment type... ...Medical Director, Medical Affairs (Remote) Chief Medical Officer... ...and Marketing - Medical Device Hudson, MA $210,000.00-$...Medical deviceContract workRemote work
- ...goals are met. Ideal candidates have a BS in STEM and a minimum of 5 years in product development or project management, ideally in medical instrumentation. The position offers a competitive salary and benefits including health insurance and retirement plans. #J-18808-...Medical device
- MBX Biosciences, Inc. is seeking a Senior Director of Medical Affairs (Strategy) to lead the Medical Affairs strategy across the portfolio, focusing... ...launch preparation and beyond. You will partner with Clinical Development, Commercial, Regulatory, and other teams to translate...
- Job Summary The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth... ...and regulatory requirements for non-medical devices, and medical devices. Assess the... ...maintenance of technical documentation (such as clinical evaluation reports, risk management...Medical deviceLocal areaRemote work
- ...Senior Clinical Data Manager The Senior Clinical Data Manager is responsible for study... ...providers (e.g., Central Reading Centers, Labs, Medical Coders). Data Management Documents:... ...in the pharmaceutical or medical device industry. Understanding of clinical trial...Medical device
$137k - $236k
...position will support software enabled medical devices with focus on major markets including the... .... Reporting to the Head of Regulatory Affairs-Enterprise Informatics/Innovation &... ...stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions. This...Medical deviceWork visa
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