Senior Regulatory Affairs Lead - Medical Devices (Hybrid)
$109k - $183kCH01 CHE Fresenius Medical Care (Schweiz) AG
CH01 CHE Fresenius Medical Care (Schweiz) AG is seeking a Principal RA Associate Devices in Waltham, MA. The ideal candidate will develop regulatory strategies for medical devices, prepare necessary FDA submissions, and oversee day-to-day project management. With a minimum of 8 years of experience in regulatory environments and prior 510(k) submission experience, the candidate must effectively collaborate with various departments and be detail-oriented.Salary ranges from $109,000 to $183,000 annually with a comprehensive benefits package. #J-18808-Ljbffr
- 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...SeniorMedical deviceRemote work
$92k - $138k
Medtronic is seeking a Senior Regulatory Affairs Specialist in Boston, Massachusetts. This role is primarily responsible for managing regulatory activities for the Basic Energy and Access and Instrument product portfolio. Duties include preparing submissions, interacting...SeniorMedical device- Johnson & Johnson is seeking a Senior Navigation Systems Software Manager in Boston, MA. You will lead an embedded software team focused on innovative surgical... ...experience and a background in medical devices. This hybrid role involves collaboration across multiple...SeniorMedical device
- Werfen is seeking an experienced regulatory professional to ensure compliance with domestic and international regulations for digital... ...requires a Bachelor's degree and a minimum of 5 years in medical devices or related sectors, along with excellent communication and problem...SeniorMedical device
$90 - $130 per hour
...Job Title Project Manager (Medical Devices III) Position Type Contract... ...manufacturing readiness, and regulatory submission activities. The Project... ...Development, Regulatory Affairs, Quality, Manufacturing, and... ...timelines. Responsibilities Lead integrated project plans...SeniorMedical deviceContract work$212k - $333.19k
...therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations... ...Reviews and approves medical device development design control... ...position is currently classified as hybrid following Takeda's Hybrid and Remote...SeniorMedical deviceMinimum wageTemporary workLocal areaRemote workWorldwideNight shift- ...Biogen, Inc. is seeking a Senior Device Quality Engineering Lead to oversee quality for medical devices. This hybrid role requires strong leadership in quality oversight during... ...will have extensive experience in regulatory compliance, design control, and risk management...SeniorMedical device
- ...support the integration of cutting-edge medical technologies in healthcare environments.... ...have 3 to 5 years of experience in medical device integration, with strong knowledge of standards... ...HL7 and DICOM. The position offers a hybrid work model, competitive pay, and...SeniorMedical device
- ...A leading biomedical company in Waltham is seeking a Senior Manager for Software Quality Assurance to oversee software compliance in medical devices. The role demands at least 10 years of experience in QA and leadership within regulated industries. Key responsibilities...SeniorMedical deviceFlexible hours
$210k - $270k
...Biomedical GmbH in Waltham, MA is seeking a Regulatory Affairs professional specializing in FDA... ...has 10-15 years of experience in IVD or medical device regulatory environments, strong... ...,000 to $270,000 annually, along with hybrid work options and a robust benefits package...Medical device$119.5k - $172.5k
...Boston, MA, is seeking an experienced Compliance Manager to oversee regulatory initiatives and compliance projects. This role requires 8-12+... ...and maintaining compliance effectiveness. The company offers a hybrid work model, competitive salary ranging from $119,500 to $172,50...Senior- Activ in Boston, MA is looking for a Senior Sustaining Engineer to lead manufacturing and engineering efforts. You will serve as the key technical contact... ...a BS in a related engineering field. You will work in a hybrid environment and collaborate with cross-functional teams....SeniorMedical deviceContract work
$115k - $140k
Werfen is looking for a Senior Quality Systems Specialist I in Bedford, MA, responsible... ...Ideal candidates will have 8+ years in medical devices or pharmaceuticals with a bachelor's in... ...a salary range of $115K to $140K, with a hybrid work model. #J-18808-Ljbffr UNAVAILABLESeniorMedical device- WSP in Boston, MA, is seeking a Senior Environmental Permitting Specialist to join their... ...strategy, agency coordination, and regulatory compliance for transportation and coastal... ...project management skills. WSP offers a hybrid working environment and substantial employee...Senior
- ...family-owned British company based in Cambridge, seeks a Senior Offset/Industrial Cooperation Manager to lead compliance and policy development in Offset... ...departments to enhance compliance and operational efficiency. A hybrid work model is offered. #J-18808-Ljbffr MarshallSenior
$120k - $150k
A medical device company in Massachusetts seeks a Regulatory Affairs lead dedicated to clinical and medical device products. This role involves overseeing FDA submissions and managing clinical studies. Candidates should have 7-10 years of experience in Clinical Affairs...SeniorMedical deviceRemote job- ...in Bedford, MA is seeking a skilled Senior Quality Lab Specialist to join their... ...Quality team. This role involves ensuring regulatory compliance, leading audits, and driving the continuous... ...Management System. The position offers a hybrid schedule after initial training and...Senior
$238k - $374k
...for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination... ...functional teams. The position offers a hybrid work model, competitive salary ranging...Medical device- ...Mass Digital Health is seeking a Senior Regulatory Affairs Specialist in Waltham, Massachusetts. In this role, you will lead the regulatory efforts for Software as a Medical Device (SaMD) across global markets, guiding product teams toward compliance. Ideal candidates...Medical device
- ...Werfen is hiring an IT Senior Analyst Programmer in Bedford, Massachusetts, focused on... ...guidance of the IT Development Manager. This hybrid position allows for 3 days in-office and... ...and extensive SAP experience, specifically in the medical devices sector. #J-18808-Ljbffr...SeniorMedical deviceWork at officeWork from home
- ...A leading healthcare organization in Somerville is seeking a Senior Manager of Infection Control. This role entails overseeing infection prevention efforts and managing... ...in healthcare settings. This role offers a hybrid work environment and competitive salary based on...Senior
$85.6k - $149.4k
...About the Role As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. You will guide product teams through compliant design and commercialization...SeniorMedical device- ...in Waltham, MA is seeking a Senior Director of Quality to ensure... ...multiple sites. This role includes leading external audits, managing... ...have 12+ years in the medical device field, strong organizational... ...degree. The position offers a hybrid work model, competitive salary...Medical device
- A leading diagnostics company in Massachusetts is seeking a senior engineer with over 8 years of product development experience in medical devices. The role involves independent evaluation of engineering assignments, technical project leadership, and complex data analysis...SeniorMedical device
- ...Candidates should possess a bachelor's degree and 5-7 years of compliance experience. The position offers competitive salaries, career growth opportunities, and a hybrid work environment, requiring on-site presence in Somerville a few times per month. #J-18808-Ljbffr...Senior
$99.37k - $122.75k
...Progress Software Corporation is seeking a Senior Technical Salesforce Business Systems Analyst to join the Enterprise Applications and... ...role and hands-on experience with Sales Cloud configuration. This hybrid position is based in Burlington, MA, offering a salary range of...Senior$220k - $300k
...with disabilities. The Senior Director of Quality... ...audits performed by regulatory bodies such as the... ...Skilled at performing and leading internal and... ...software 12+ years of medical diagnostic or device experience managing... ...PTO and paid holidays Hybrid and flexible work...SeniorMedical deviceHourly payWork at officeFlexible hours$160k - $180k
...The ideal candidate will have a Bachelor’s degree and a proven track record in sales and business development, particularly with medical device OEMs. You will develop effective business strategies, collaborate with engineering teams, and maintain strong client...SeniorMedical deviceRemote job$110k - $125k
...Paragonix Technologies, Inc. is looking for a Senior Clinical Research Associate in Boston,... ..., and ensuring compliance with regulatory standards. The candidate should have at... ...clinical research, preferably within the medical device or pharmaceutical industry. The position...SeniorMedical deviceRemote work- ...A mental health clinic in Newton, MA is seeking licensed mental health counselors to join their team. This hybrid role emphasizes creativity, providing a supportive environment prioritizing clinician needs. Responsibilities include supervising counselors, evaluating mental...Senior
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