Job Type
Date Posted
Salary Range
Distance

Quality Assurance/Regulatory Affairs Engineer Jobs in Waltham, MA

43 Jobs

  • 2.6
    MRI Boston Group – Boston, MA
    19 days ago 19d
    DIRECTOR, QUALITYASSURANCE/REGULATORYAFFAIRS will: Manage QualityAssurance, Quality Control, RegulatoryAffairs, Supplier… The DIRECTOR, QUALITYASSURANCE/REGULATORYAFFAIRS will have: BS/MS in Life Science or Engineering 10+ years’ experience…
  • 3.5
    C. R. Bard, Inc. – Woburn, MA
    $77k-$113k(Glassdoor est.)
    HOT
    science or engineering. RegulatoryAffairs Specialist: Minimum of three years knowledge and experience with regulatory requirements… Responsibilities The position of RegulatoryAffairs Specialist / Sr. RegulatoryAffairs Specialist will be responsible to provide…
  • Advanced Instruments – Boston, MA
    $98k-$138k(Glassdoor est.)
    30+ days ago 30d+
    direct regulatory strategies for new products. Manage regulatoryaffairs, quality control, qualityassurance, supplier quality, calibration… analysis. We are currently seeking a Director of Quality Control & RegulatoryAffairs to join our team.…
  • 3.8
    Brigham and Women's Hospital – Boston, MA
    NEW
    Director of Environmental Affairs will preferably hold an advanced degree (M.S. or Ph.D.) in engineering, in a relevant scientific… monitor and supervise work; assure compliance with established policies and procedures; control quality and quantity of work performed…
  • 4.0
    Sekisui Diagnostics – Lexington, MA
    $78k-$116k(Glassdoor est.)
    17 days ago 17d
    and regulatory training/mentoring to other RegulatoryAffairs employees and cross-functional teams. Provide regulatory representation… product development, design controls, design assurance, sustaining engineering and regulatory business systems. Provide expertise and…
  • 3.5
    Surgical Specialties – Braintree, MA
    $61k-$87k(Glassdoor est.)
    7 days ago 7d
    President of Quality / RegulatoryAffairs, the Senior RegulatoryAffairs Specialist is responsible for preparing regulatory submissions… years experience in RegulatoryAffairs in the medical device/drug industry. Must have experience with regulatory registration and/…
  • 3.8
    Hologic – Marlborough, MA
    $76k-$107k(Glassdoor est.)
    13 days ago 13d
    professionals. Role The Senior RegulatoryAffairs Specialist provides medical device RegulatoryAffairs expertise by participating… A Senior RegulatoryAffairs Specialist provides global Regulatory support to cross functional teams working on a range of products…
  • 3.8
    Brigham and Women's Hospital – Boston, MA
    NEW
    Director of Environmental Affairs will preferably hold an advanced degree (M.S. or Ph.D.) in engineering, in a relevant scientific… monitor and supervise work; assure compliance with established policies and procedures; control quality and quantity of work performed…
  • 3.8
    Olympus Corporation of the Americas – Southborough, MA
    $58k-$84k(Glassdoor est.)
    10 days ago 10d
    manufacturing, engineering, qualityassurance, product development, and clinical affairs as required to assureregulatory compliance… consider. * The RegulatoryAffairs Specialist will help ensure Olympus Surgical Technologies America (OSTA) quality system and EU…
  • 3.1
    Olympus – Southborough, MA
    $55k-$79k(Glassdoor est.)
    6 days ago 6d
    manufacturing, engineering, qualityassurance, product development, and clinical affairs as required to assureregulatory compliance… consider. * The RegulatoryAffairs Specialist will help ensure Olympus Surgical Technologies America (OSTA) quality system and EU…
  • 3.8
    Brigham & Women's Hospital(BWH) – Boston, MA
    $111k-$164k(Glassdoor est.)
    NEW
    Director of Environmental Affairs will preferably hold an advanced degree (M.S. or Ph.D.) in engineering, in a relevant scientific… monitor and supervise work; assure compliance with established policies and procedures; control quality and quantity of work performed…
  • 3.4
    Philips – Andover, MA
    $73k-$105k(Glassdoor est.)
    NEW
    capabilities: Regulatory&Clinical Affairs, Supplier Quality, Quality Management System, QualityAssurance&Engineering, and Compliance… TitleQuality Engineer - Software Job Description Your challenge As the incumbent of this Quality&Regulatory (Q&R) role…
  • 3.3
    Fresenius Medical Care - North America – Waltham, MA
    NEW
    guidelines. Knowledge of FDA regulatory requirements (GMP/QSR) and of standard qualityassurance practices for manufacturing operations… support documents, test articles and reports. Assists RegulatoryAffairs on issues related to 510(K), IDE and NDA submissions.…
  • 3.6
    Medtronic – Mansfield, MA
    $100k-$137k(Glassdoor est.)
    26 days ago 26d
    strategies for RegulatoryAffairs. Collaborate with R&D, Clinical, and Quality and other required functions to execute regulatory strategy… access, and quality of life for patients affected by renal disease. POSITION DESCRIPTION The RegulatoryAffairs Manager is…
  • 3.4
    Philips – Andover, MA
    $77k-$107k(Glassdoor est.)
    NEW
    capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, QualityAssurance & Engineering, and Compliance… processes and execution excellence; including Product QualityEngineering (PQE) portfolio management. Reports to the Head of PQE…
  • 3.4
    Insulet Corporation – Billerica, MA
    $111k-$151k(Glassdoor est.)
    6 days ago 6d
    Operations, and Information Technology, Engineering, New Business Development and RegulatoryAffairs) as well as other external parties… This position is responsible for leading QualityAssurance and QualityEngineering activities throughout the Software Development…
  • 2.7
    Shire – Lexington, MA
    $94k-$130k(Glassdoor est.)
    HOT
    Internal Manufacturing, Engineering, Supply Chain, Quality Control, QualityAssurance, and RegulatoryAffairs External: CMOs… Vendors, Regulatory Agencies Education And Experience Requirements Degree in Chemical Engineering, Biochemical Engineering or…
  • 3.6
    Medtronic – Danvers, MA
    4 days ago 4d
    to the quality system You will partner with R&D, Operations, RegulatoryAffairs, Component Engineering, and quality support… The Sr Design AssuranceEngineer (DAE) serves as a CardioVascular subject matter expert in a qualityengineering capacity for the…
  • 3.6
    Siemens Healthineers – Norwood, MA
    7 days ago 7d
    target timelines, budget and quality Report to Director, Pre-Market Clinical & RegulatoryAffairs, Quality Technology, Point of Care… relevant job areas Work cross-functionally with RegulatoryAffairs and Quality Management, as workload permits, to support efforts…
  • Unum Therapeutics – Cambridge, MA
    EASY APPLY
    13 days ago 13d
    substance, drug product, and finished goods. Partner with RegulatoryAffairs and Manufacturing to raise and/or resolve any change control… Manager/Senior Manager of GMP QualityAssurance who wants to help us build out our GMP Quality processes and systems as we look…
  • 2.7
    Angiotech – Braintree, MA
    $64k-$91k(Glassdoor est.)
    30+ days ago 30d+
    President of Quality / RegulatoryAffairs, the Senior RegulatoryAffairs Specialist is responsible for preparing regulatory submissions… years experience in RegulatoryAffairs in the medical device/drug industry. Must have experience with regulatory registration and/…
  • 3.0
    Fresenius Medical Care – Waltham, MA
    16 days ago 16d
    guidelines. Knowledge of FDA regulatory requirements (GMP/QSR) and of standard qualityassurance practices for manufacturing operations… support documents, test articles and reports. Assists RegulatoryAffairs on issues related to 510(K), IDE and NDA submissions.…
  • 3.6
    Siemens Healthineers – Norwood, MA
    7 days ago 7d
    target timelines, budget and quality Report to Director, Pre-Market Clinical & RegulatoryAffairs, Quality Technology, Point of Care… relevant job areas Work cross-functionally with RegulatoryAffairs and Quality Management, as workload permits, to support efforts…
  • 3.3
    BD – Andover, MA
    $92k-$133k(Glassdoor est.)
    NEW
    individual will work closely with R&D, QualityEngineering, Medical Affairs, RegulatoryAffairs and Manufacturing to plan and execute… improving the lives of people with Diabetes. The Human Factors Engineer role resides in the Design Validation group that is responsible…
  • 3.6
    Medtronic Inc. – Danvers, MA
    $75k-$96k(Glassdoor est.)
    17 days ago 17d
    Corporate Policies. Assist RegulatoryAffairs and Engineeringpersonnel in new product/process design to assure effective control proceduresare… regulated industry with BS Degree.Less than one year of qualityassurance experience with Masters Degree. DESIRED/PREFERREDQUALIFICATIONS…
  • 3.6
    Medtronic – Danvers, MA
    10 days ago 10d
    to the quality system You will partner with R&D, Operations, RegulatoryAffairs, Component Engineering, and quality support… Principal Design AssuranceEngineer (DAE) serves as a CardioVascular subject matter expert in a qualityengineering capacity for the…
  • 3.8
    Brigham and Women's Hospital – Boston, MA
    $111k-$164k(Glassdoor est.)
    30+ days ago 30d+
    Director of Environmental Affairs will preferably hold an advanced degree (M.S. or Ph.D.) in engineering, in a relevant scientific… monitor and supervise work; assure compliance with established policies and procedures; control quality and quantity of work performed…
  • 3.4
    Philips – Andover, MA
    18 days ago 18d
    capabilities: Regulatory&Clinical Affairs, Supplier Quality, Quality Management System, QualityAssurance&Engineering, and Compliance… Job TitleSoftware AssuranceEngineer Job Description The Software AssuranceEngineer is responsible for enforcing the…
  • newtoncolmore – Boston, MA
    EASY APPLY
    NEW
    Affairs, QualityAssurance and Field Service Engineering sectors.… Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs…
  • 3.4
    Philips – Andover, MA
    $73k-$105k(Glassdoor est.)
    14 days ago 14d
    capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, QualityAssurance & Engineering, and Compliance… that deliver high quality and outstanding reliability to the lives they will improve. The QualityEngineer is accountable for…
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