• Parexel (Boston, MA)
    Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated...updates, CMC changes). - Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.… more
    DirectEmployers Association (12/20/25)
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  • Integra LifeSciences (Braintree, MA)
    …+ Ensure calibration records are complete, traceable, and compliant with FDA , ISO, and internal standards. + Troubleshoot and resolve calibration-related issues ... systems and compliance requirements. + Support installation, qualification, and validation of new instruments and equipment, ensuring adherence to...preferred. + Strong knowledge of ISO 17025, ISO 13485, FDA 21 CFR Part 11, and GMP compliance. +… more
    DirectEmployers Association (01/07/26)
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  • Integra LifeSciences (Braintree, MA)
    …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
    DirectEmployers Association (10/25/25)
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  • Olympus Corporation of the Americas (Westborough, MA)
    …designinputs, product design implementation, verification testing and supporting design validation studies. The ideal candidateis a hands-on technical leader with ... and Product Requirements. + Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements andapplicable… more
    DirectEmployers Association (11/12/25)
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  • Teleflex (Mansfield, MA)
    …nonconformances using (NC) process - First article inspections and product/process validation activities - Perform creation and inspection of product identification ... - Support document control activities (Agile updates, work package validation & storage) - Perform IV lab tests -...the medical device industry preferred - Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired -… more
    DirectEmployers Association (10/30/25)
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  • GRAIL (Boston, MA)
    …and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change ... and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US...and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US… more
    DirectEmployers Association (12/03/25)
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  • Olympus Corporation of the Americas (Westborough, MA)
    …for Human Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering to Medical Devices ... Guidance for Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content of Human Factors Information in Medical Device Marketing Submissions… more
    DirectEmployers Association (11/14/25)
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  • Olympus Corporation of the Americas (Westborough, MA)
    …Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise SW development teams on ... and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices. + Collaborate on the update of SDLC and operations… more
    DirectEmployers Association (01/06/26)
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  • Director, Commercial Manufacturing…

    Sumitomo Pharma (Boston, MA)
    …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
    Sumitomo Pharma (12/12/25)
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  • Senior Manager Cleaning Validation

    Bristol Myers Squibb (Devens, MA)
    …maintenance, and responding to compliance requirements. + Strong knowledge of cGMP, FDA , EMA, and ICH cleaning validation requirements. + Experience with ... lives. Read more: careers.bms.com/working-with-us . **Position:** Senior Manager Cleaning Validation **Location** : Devens, MA **Key Responsibilities:** + Provide… more
    Bristol Myers Squibb (01/16/26)
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