Senior Regulatory Affairs Lead Medical Devices
$105k - $168kPhilips International
Philips International is looking for a Senior Regulatory Affairs Specialist in Bedford, MA. The role involves ensuring that Philips Image Guided Therapy products comply with global regulatory requirements. Responsibilities include providing regulatory expertise for 510(k) submissions and EU MDR compliance, leading regulatory strategies, and mentoring other professionals. A minimum of 5 years of experience in a similar role is required. This position offers a salary range of $105,000 to $168,000, with additional benefits including PTO and 401k matching. #J-18808-Ljbffr Philips International
$105k - $130k
...market and/or post‑market regulatory activities for digital... ...from management or senior regulatory staff, the... ...in analyzing software medical device products and regulations... ...plans as regulatory lead for new products or significant... ...regarding regulatory affairs with all functional...SeniorMedical deviceLocal areaWorldwide$105k - $168k
...The Senior Regulatory Affairs Specialist plays a critical role in ensuring Philips Image Guided... ...hardware systems and complex device portfolios. Lead and influence global regulatory strategies... ...Affairs within FDA regulated Medical Device environments including regulatory...SeniorMedical deviceFull timeWork at officeLocal areaWork visaRelocation package3 days per week- ...in Burlington, MA is seeking an experienced Quality Manager to lead its Quality Assurance department in a dynamic engineering environment... ...involves overseeing the Quality Management System, driving regulatory compliance, and managing a quality team through product...SeniorMedical device
$110k - $115k
...Senior International Regulatory Affairs Specialist Company Description Butterfly Network, Inc. (NYSE:... ...probe, whole-body portable ultrasound device, which is now on its best-selling,... .... In addition to its medical imaging products, Butterfly Embedded...SeniorMedical deviceWork at officeImmediate startWork visaFlexible hours2 days per week$135k - $160k
...catheter-, software-, electromechanical-based medical device product families. Provide Quality... ...with R&D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance... ...and other applicable requirements • Lead cross functional teams to implement and...SeniorMedical device$85.6k - $149.4k
...Senior Regulatory Affairs Specialist 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...SeniorMedical device- ...meaningful difference in people's lives. Our medical devices, software and related services are used worldwide... ...be a part of ZOLL! Job Summary The Senior Regulatory Affairs Program Specialist is responsible for leading the collaboration with cross-functional...SeniorMedical deviceMinimum wageOngoing contractLocal areaRemote workWorldwide
- ...Senior Regulatory Specialist Dentsply Sirona is the world's largest... ...as well as other consumable medical devices under a strong portfolio of... ...life sciences, regulatory affairs, or a related discipline... ...device industry Experience with leading regulatory submissions and...SeniorMedical deviceWork at officeRemote workWorldwide
$68 - $72 per hour
...Inc. in Bedford, MA is searching for a Medical Device Development Engineer. The successful candidate... ...designing mechanical components, leading design verification projects, and... ...various teams to ensure compliance with regulatory standards. Ideal applicants will have strong...SeniorMedical deviceHourly pay$154k - $182k
...Senior Manager, Regional Regulatory Lead-North America for Vaccines CSL Seqirus is a leading global vaccine company, dedicated to advancing and protecting... ...to play a critical role within Global Regulatory Affairs & Safety (GRAS) organization. The role can be located either...SeniorLocal area3 days per week$110k - $125k
...We are currently seeking a Senior Scientist II - Sensor Development... ...Assist technical lead in building, testing and troubleshooting... ...controls. Collaborate with regulatory to develop analytical... ...of IVD (In Vitro Diagnostic) medical devices, particularly electrochemical...SeniorMedical deviceWork at officeFlexible hours- Adecco is seeking a Buyer/Senior Buyer in Bedford, MA, to support procurement activities in the Medical Device sector. This is a contract position with a possibility of becoming permanent. The ideal candidate will have strong SAP experience and a background in manufacturing...SeniorMedical devicePermanent employmentContract work
$160k - $190k
A leading organization in healthcare is seeking a Patent Agent to provide high-quality intellectual property services. The role involves managing patent portfolios, implementing IP strategies, and supporting due diligence. Candidates must hold a bachelor's degree in science...SeniorMedical device- ...in Bedford, MA is seeking a Contract Clinical Trial Manager to lead the operational aspects of clinical trials. This role involves... ...extensive clinical research experience, particularly within medical devices. Responsibilities include budget management, quality oversight...Medical deviceContract work
$140k - $180k
...Trident Consulting is seeking a " Senior Product Security Engineer”... ...on securing embedded medical devices across the full product lifecycle... ...by design and aligned with regulatory expectations. This... ...connected medical devices Lead secure-by-design initiatives...SeniorMedical deviceFull timeContract workRelocation package- ...Senior BI Team Lead Apex Systems is a world-class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. Apex has an opportunity for a Senior BI Team Lead role in the Boston...SeniorContract work
$118.5k - $148.1k
...seeking an "Cybersecurity GRC Lead " for one of our clients in... ..., with strong exposure to medical devices, healthcare technology, life... ...multi-factor cybersecurity and regulatory issues, applying sound... ...influencing cross-functional and senior stakeholders (Engineering,...Medical deviceFull timeContract workWork at office3 days per week- ...You'll Do: The Cybersecurity GRC Lead - Medical Devices (Continuous Control Monitoring Lead)... ...with Engineering/R&D, Quality, Regulatory Affairs, IT, and Information Security to maintain... ...influencing cross-functional and senior stakeholders (Engineering, Quality,...Medical deviceLocal area
$150k - $200k
...Senior Embedded Software Engineer Bedford, MA Company Overview Lexington Medical, Inc. is a medical device company developing and manufacturing minimally... ...In this role, you will lead the design, development... ..., and collaborate with regulatory, quality, and manufacturing...SeniorMedical deviceWorldwide$109k - $121k
...standards for Ocular's pharmaceutical and medical device products by managing activities... ...background and experience of the candidate. The Senior Associate, Quality Compliance is... ...improvements and achieve adherence with regulatory expectations: Risk Management, Internal...SeniorMedical deviceLocal area- ...What You'll Do The Senior Complaint Specialist ensures global... ...the full lifecycle of medical device complaints, including intake, evaluation, investigation, regulatory reporting, resolution, and closure... ...Conduct root cause analyses, lead complaint investigations, and...SeniorMedical deviceFull timeWork at officeImmediate start
- ...Senior Program Quality Lead (PQL) Join our team as a Senior Program Quality Lead (PQL) supporting the Advanced Technologies (AT) Strategic Business Unit. Program Quality drives customer, program, and business success by effectively synthesizing the support and results...SeniorWork experience placementRemote workRelocation package
$91.7k - $137.53k
...Position Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations... ...initiatives to ensure regulatory approval of medical devices in both domestic and international markets. Provide...SeniorMedical deviceWork at office- ...document change assessments for US Class II devices to ensure compliance with the US... ...devices to ensure compliance with the EU Medical Device Regulation. Plan and prepare submissions... ...compiling documents for submission to regulatory authorities, as well as assisting in...Medical deviceWorldwide
$99.37k - $122.75k
Progress Software Corporation is seeking a Senior Technical Salesforce Business Systems Analyst to join the Enterprise Applications and Data team. You will analyze, design, and implement Salesforce solutions while documenting workflows and managing project work end-to-...Senior$157k - $249k
...Senior Softw are Architect - Integration (Bedford... ...the Image Guided Therapy Devices (IGT-D) team, you will... ...compliant, and innovative medical software products.... ...business strategy and regulatory requirements. Functional... ...a proven ability to lead and influence senior technical...SeniorMedical deviceFull timeTemporary workWork at officeLocal areaWork visaRelocation package3 days per week$130k - $150k
...seeking a " Sr. Product Security Engineer (Medical Devices) " for one of our clients in "... ...About the Role: We are seeking a Senior Product Security Engineer to join our team... ...are secure by design and aligned with regulatory expectations. This position sits within...SeniorMedical deviceFull timeContract work$133.3k - $166.6k
...Role Reporting to the Vice President of Marketing, the Senior Manager of Lead Management owns the strategy, mechanics, and processes for... ...package including paid time off, charitable giveback day, medical/dental/vision insurance, and retirement benefits to eligible...Senior- ...About Zifo: Zifo is a leading global scientific informatics... ...North America is seeking a Senior Scientific Business Systems... ...organizations. ~ Contribute to regulatory and data integrity... ...Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other...SeniorMedical deviceFull timeRelocation packageFlexible hours
$160k - $180k
...parts, processes, software or components of medical diagnostic systems. Independently... ...Key Accountabilities Essential Functions: Lead testing activities including Software Feature... ...internal design controls and applicable medical device regulations and standards (e.g., ISO 1348...SeniorMedical deviceFull timeWorldwideShift work
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