Quality Assurance/Regulatory Affairs Engineer Jobs in Waltham, MA | Glassdoor

Quality Assurance/Regulatory Affairs Engineer Jobs in Waltham, MA

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  • 2.5
    Cbr Systems – Waltham, MA
    Est. Salary $60k-$94k
    7 days ago 7d
    Technical Operations, Quality Control, Clinical Operations, Quality Assurance Systems, Regulatory Affairs, and Pharmacovigilance… Support, maintain, and further enhance Quality Assurance Operations as related to product quality and overall compliance within the…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $59k-$127k
    25 days ago 25d
    portfolio of products. Partner with Quality Assurance and Regulatory Affairs to ensure that high quality standards are maintained and… products and reference standards. Provide input and data for regulatory filings. Actively participate in the design of specifications…
  • 3.6
    Alkermes – Waltham, MA
    Est. Salary $152k-$198k
    13 days ago 13d
    teams such as supply chain, quality assurance, engineering, manufacturing, EHS and regulatory affairs to provide technical input… Knowledge of global regulatory requirements and industry best practice concerning cGMP manufacturing, validation, quality systems, equipment…
  • 3.3
    AMAG Pharmaceuticals, Inc – Waltham, MA
    Est. Salary $75k-$112k
    6 days ago 6d
    Technical Operations, Quality Control, Clinical Operations, Quality Assurance Systems, Regulatory Affairs, and Pharmacovigilance… Support, maintain, and further enhance Quality Assurance Operations as related to product quality and overall compliance within the…
  • Alere Accountable Care Solutions – Waltham, MA
    18 days ago 18d
    Title: RA Specialist Department: Quality Assurance Reports to: Regulatory Manager Term: Full-time, Continuing… experience acceptable to Epocal 3-5 years’ experience in Regulatory Affairs, within ISO 13485 registered product development and manufacturing…
  • 3.6
    Alkermes – Waltham, MA
    Est. Salary $136k-$180k
    21 days ago 21d
    teams such as supply chain, quality assurance, quality control, engineering, and regulatory affairs to provide input and generate… procedures to ensure maintenance of technical best practice and regulatory compliance across the API supply network to ensure reliability…
  • 3.7
    BioReliance – Danvers, MA
    Est. Salary $61k-$82k
    1 days ago 19hr
    with other quality functions such as manufacturing site quality, quality systems, regulatory affairs, external quality groups, etc… Qualifications: • 4-9 years progressive, seasoned design assurance engineering within the biopharma. biotech, or medical device industries…
  • Alere Accountable Care Solutions – Waltham, MA
    20 days ago 20d
    and quality assurance decisions as needed to: QA, Operations, R&D, Sales and Marketing, Technical Service, Clinical Affairs and… effectiveness of the QMS. Assures all government and international report systems and documentation comply with regulatory requirements for…
  • 3.8
    Olympus Corporation of the Americas – Southborough, MA
    Est. Salary $59k-$91k
    7 days ago 7d
    preferably in engineering or life science; Master's Degree is preferred. * Minimum of 3 years of Regulatory Affairs experience in… Territory Manager, International Regulatory Affairs will support international regulatory affairs activities, including but not limited…
  • 3.5
    Merck KGaA – Danvers, MA
    Est. Salary $73k-$97k
    1 days ago 22hr
    with other quality functions such as manufacturing site quality, quality systems, regulatory affairs, external quality groups, etc… Qualifications: • 4-9 years progressive, seasoned design assurance engineering within the biopharma. biotech, or medical device industries…
  • 3.6
    Alkermes – Waltham, MA
    Est. Salary $152k-$198k
    30+ days ago 30d+
    teams such as supply chain, quality assurance, engineering, manufacturing, EHS and regulatory affairs to provide technical input… Knowledge of global regulatory requirements and industry best practice concerning cGMP manufacturing, validation, quality systems, equipment…
  • 2.5
    ConforMIS – Bedford, MA
    Est. Salary $56k-$78k
    5 days ago 5d
    assessments, project and validation plans. Work with Regulatory Affairs to prepare documentation for FDA 501K submissions. Other… Software Quality Engineer/Technical Writer Job Description: The Software Quality Engineer/Technical Writer…
  • 3.6
    Medtronic – Boston, MA
    Est. Salary $130k-$213k
    3 days ago 3d
    device industry in a regulatory, clinical, R&D or quality function 5 years’ experience in regulatory affairs 7 years people management… The Director of Regulatory Affairs, reports directly to the Vice President of Regulatory Affairs, Surgical Innovations. This…
  • 4.2
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $87k-$162k
    13 days ago 13d
    collaboratively with Clinical Operations, Quality Assurance, CMC and Regulatory Affairs to efficiently deliver clinical supplies… pharmaceutics, chemistry, biology, material science, chemical engineer or related disciplines with 5+ years of direct hands on clinical…
  • 3.6
    Medtronic Inc. – Framingham, MA
    Est. Salary $84k-$114k
    5 days ago 5d
    and other reliability inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and… post market reliability engineering in conjunction with Market Release. * For work performed, assure compliance to organizational…
  • 3.4
    Vertex Pharmaceuticals – Boston, MA
    Est. Salary $73k-$98k
    2 days ago 2d
    with teams such as supply chain, quality assurance, engineering, artwork and regulatory affairs groups to provide input into packaging… component qualification, - Knowledge of cGMPs and associated regulatory considerations in a commercial pharmaceutical packaging environment…
  • 2.9
    Massachusetts Department of Children and Families – Boston, MA
    6 days ago 6d
    prevent illness, injury, and premature death, to assure access to high quality public health and health care services, and to promote… regulations, and sub-regulatory documents; and prepare policy briefs and statutory, regulatory, and sub-regulatory proposals; Communicate…
  • 3.9
    Executive Office of Labor and Workforce Development – Boston, MA
    6 days ago 6d
    prevent illness, injury, and premature death, to assure access to high quality public health and health care services, and to promote… regulations, and sub-regulatory documents; and prepare policy briefs and statutory, regulatory, and sub-regulatory proposals; Communicate…
  • 3.1
    Sanofi U.S. – Cambridge, MA
    Est. Salary $80k-$129k
    13 days ago 13d
    Division, Global Marketing, Global Medical Affairs, Corporate and local Regulatory, GPE, R&D and IQC.• Transfer responsibility… controls are implemented, verified and validated.• Assures that Sanofi quality and compliance standards and applicable government…
  • 3.5
    Sanofi – Cambridge, MA
    Est. Salary $82k-$132k
    13 days ago 13d
    Division, Global Marketing, Global Medical Affairs, Corporate and local Regulatory, GPE, R&D and IQC. • Transfer responsibility… controls are implemented, verified and validated. • Assures that Sanofi quality and compliance standards and applicable government…
  • 2.1
    Valeant – Boston, MA
    Est. Salary $91k-$140k
    12 days ago 12d
    Experience in Regulatory Affairs is highly desired. Minimum 10 years of experience in Medical Device Quality Management. Proven… years Quality Assurance experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies…
  • 2.8
    Bausch & Lomb – Boston, MA
    Est. Salary $118k-$179k
    10 days ago 10d
    Experience in Regulatory Affairs is highly desired. Minimum 10 years of experience in Medical Device Quality Management. Proven… years Quality Assurance experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies…
  • 3.5
    Insulet Corporation – Billerica, MA
    2 days ago 2d
    medical devices. A minimum of 3 years in a Quality Assurance or Regulatory Affairs role. Skills/Competencies: Effective… documents and quality records. The position is engaged in improvement projects, ensuring efficient and compliant quality systems, and…
  • 3.2
    Boston Biomedical, Inc. – Cambridge, MA
    Est. Salary $89k-$141k
    29 days ago 29d
    – understands quality principals 7+ years in pharmaceutical Quality Assurance Science, Math or Engineering degree Company… manufacturing and control), global clinical trials and regulatory affairs. Our scientists have established a track record of accomplishments…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $174k-$240k
    22 days ago 22d
    vaccine regulatory affairs team on cross-function Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc)… Analytical Development, Production, Quality Assurance). Proven ability to liaise with Regulatory Agencies in Agency Interactions…
  • 2.5
    uniQure – Lexington, MA
    Est. Salary $93k-$138k
    15 days ago 15d
    disciplines within Operations: Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Technical Services, and Facility Management… and provide effective leadership to Manufacturing, Engineering and Quality functions Able to keep up performance under stress…
  • Ocular Therapeutix – Bedford, MA
    Est. Salary $74k-$107k
    22 days ago 22d
    The Regulatory Affairs Project Manager will work with Regulatory management and project team members to identify and execute… of global regulatory guidelines and requirements 7 – 10 years of experience in pharmaceutical Regulatory Affairs related to…
  • 3.5
    Insulet Corporation – Billerica, MA
    Est. Salary $131k-$185k
    8 days ago 8d
    initiation through study closeout, as well as assuring compliance with regulatory and quality procedures and standards. Lead the planning… Responsibilities: Work with Regulatory Affairs to manage US and international regulatory submissions for the conduct of clinical…
  • 2.8
    Bausch & Lomb – Boston, MA
    Est. Salary $118k-$179k
    21 days ago 21d
    Experience in Regulatory Affairs is highly desired. Minimum 10 years of experience in Medical Device Quality Management. Proven… years Quality Assurance experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies…
  • 3.6
    GE Healthcare – Marlborough, MA
    7 days ago 7d
    Imaging Technology, Regulatory Affairs; Medical Affairs, Portfolio/Program Management, Quality Assurance; Pharmacovigilance; Finance… research studies Quality/Regulatory Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality Management System…
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