Senior Regulatory Affairs Specialist
BrioHealth Solutions, Inc.
BrioHealth Solutions is seeking a Senior Regulatory Affairs Specialist to support the BrioVAD LVAS. This role partners with clinical, R&D, quality, and medical affairs teams to drive regulatory planning, submissions, and lifecycle management. You will manage FDA submissions, advise on labeling and study documentation, and help navigate EU MDR and CE marking efforts for class III devices. Candidates should bring strong technical writing and project leadership. #J-18808-Ljbffr
- ...Senior Regulatory Affairs Specialist BrioHealth Solutions is seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support the BrioVAD® Left Ventricular Assist System. This individual will partner with cross-functional teams to support product...Senior
- BRIOHEALTH SOLUTIONS INC, based in Massachusetts, seeks a Senior Regulatory Affairs Specialist to lead FDA submissions and regulatory planning for BrioVAD LVAS. You will partner with cross-functional teams to ensure compliance across US and EU programs, including IDE/PMAs...Senior
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and... ...and collaboration with cross-functional teams. This mid-senior position focuses on ensuring timely, compliant filings in...SeniorFull time
- The Sr. RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign). Ensure implementation and maintenance of regulatory filing... ...agenciesAssist with other basic Regulatory Affairs functions, such as scanning and archiving records Other...SeniorLocal area
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities to secure timely product clearances. Responsibilities...SeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week$101.6k - $131.9k
...tough problems. Job Summary Responsible for supporting regulatory activities regarding released product, including, MDR investigations... ...field required. A minimum of 4 years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510...SeniorShift work- ...support the creation of increased transfer opportunities in complex federal and private-sector landscapes, the Laboratory is seeking a Senior Technology Licensing Officer. This position will have the unique opportunity to work with cutting-edge technologies and collaborate...SeniorContract workWork at office
- Sun Pharmaceutical Industries, Inc (USA) seeks a Sr. Associate Compliance to provide scientific support for root cause analysis and closure of OOS and OOT investigations and product quality complaints. You will ensure GLP and cGMP compliance and contribute to the Quality...Senior
- Sr. Regulatory Affairs Specialist role at Glaukos Corporation Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA) The Sr. RA Specialist is Responsible... ...with applicable regulations and Glaukos internal SOPs. Seniority level Mid-Senior level Employment type Full-time Job...SeniorFull time
$140k - $180k
...including third-party risk, control testing, and audit readiness—while ensuring the organization is prepared for certifications and regulatory requirements. Additionally, you will enhance our security posture through automation, continuous monitoring, and proactive...Senior- ...assess vendor SCAR (Supplier Corrective Action Reports) and ensure effective follow-up.Ensure vendor-supplied products comply with regulatory and quality standards.Develop and maintain strong, long-term relationships with approved vendors.Evaluate new vendor capabilities...Senior
$147.4k
Posting Description SENIOR LICENSING AND BUSINESS DEVELOPMENT OFFICER, Technology Licensing Office, is responsible for the commercialization of MIT’s IP portfolio arising from research and activities on MIT’s campus; managing a large portfolio of cases, including, technology...SeniorFull timeWork at officeVisa sponsorship- AspenTech is seeking a Sr Principal Solution Consultant to partner with the sales team to lead discovery sessions, craft strategic solutions, and design customer-focused implementation strategies. You will leverage deep industry knowledge for Metals & Mining, Specialty ...Senior
- EMD Serono seeks a Senior Principal Biostatistician to shape the statistical foundation of life‑changing medicines. You will serve as a Statistical Subject Matter Expert at the program level, designing, analyzing, and interpreting data across clinical and observational...Senior
- A leading technology company is seeking a Senior Principal Software Engineer to join their Xcelium Compiler Team. This role focuses on implementing advanced compiler algorithms and collaborating on strategic architectural initiatives for simulation technologies. Candidates...Senior
- Baker Tilly is seeking a Senior Consultant (Life Sciences - Compliance) to join its Risk Advisory practice. You will work on a variety... ..., including compliance program development, data analysis, and regulatory risk assessment, leveraging strong analytics and client-facing...Senior
- ...Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.As a Senior Clinical Regulatory Specialist at Iterative Health, you will play a key role in supporting the compliant execution of Phase 2-4 industry-sponsored...SeniorTemporary workWork at office2 days per week
- Charles River Laboratories seeks an experienced Senior Principal Scientific Advisor to join our Safety Assessment team. The role provides... ...leadership in diverse modalities and a solid understanding of regulatory expectations to inform risk-based development strategies for...Senior
- Keurig Dr Pepper Inc. is seeking a Senior Principal Toxicologist in Burlington, Massachusetts. This role involves managing toxicology activities to support the development of safe food and beverages. You will work closely with various departments to ensure compliance and...Senior
- ...Position Overview This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements...Local areaRemote workFlexible hours
- ...Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II supports regulatory submissions and regulatory authority interactions related... ...launch business maintenance activities under the guidance of Senior Regulatory Affairs personnel.• Reviews labeling and...
- ...markets worldwide.Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities.Assist in external audits by...Worldwide
- ...Anika-GCC in Bedford, MA is seeking a Regulatory Affairs Specialist II to support regulatory submissions and regulatory authority interactions related to product submissions and approvals. You will prepare and submit regulatory documentation, support product market approval...
$195k - $270k
Senior Principal Systems Engineer - Hanscom As aSenior Principal Systems Engineer with MTSI you will provide technical and programmatic advice and support services on a suite of fast paced, high consequence novel architectural initiatives aimed at advancing the DAF C3BM...SeniorContract workWork experience placement- ...Senior/Principal Scientist, MPN Biology, Translational Sciences PharmaEssentia Innovation Research Center (... ...optimization, and therapeutic target validation. Regulatory Interaction: Work with regulatory affairs to support the preparation and review of regulatory...SeniorContract work
- Modern Technology Solutions, Inc. (MTSI) is seeking a Cyber Security - Information Systems Security Engineer ( ISSE) in Dayton, OH or Hanscom Air Force Base, MA. As a Cybersecurity Engineer / Information Systems Security Engineer (ISSE) with MTSI you will support a customer...SeniorFor contractorsWork at office
$180k - $220k
DescriptionLocation: Remote position. Occasional travel to our office in Golden, Colorado is required.About PenteraPentera is the global leader in Automated Security Validation, helping organizations worldwide safely emulate real-world attacker behavior and uncover their...SeniorWork at officeRemote workWorldwide$154.4k - $242.55k
...true to the best of my knowledge.Job DescriptionJoin Takeda as a Senior/Principal Scientist, Cell Based-Potency Assay Development. As... ...development, GMP release and stability testing, comparability, regulatory submissions, and analytical control strategy. You will bring deep...SeniorMinimum wageContract workTemporary workLocal area$175k - $200k
Senior Principal Software Engineer - Xcelium Compiler Team (R51299/ts) We are seeking a highly skilled and motivated Senior Principal Engineer to join the Xcelium Compiler Team. The responsibilities will include implementing advanced compiler algorithms, profiling and...Senior- Anika is seeking a Regulatory Affairs Specialist II to support regulatory submissions, authority interactions, and post-approval activities. The role requires preparing documentation, maintaining compliance, and guiding cross-functional teams through regulatory processes...
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