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Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Deep understanding of CDISC standards and regulatory submission requirements.
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There will be interdepartmental interactions surrounding Post Market Surveillance activity involving Quality Assurance Engineering, Compliance, Technical Support, Service, and Regulatory Affairs.
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Title: Senior Regulatory Affairs Specialist-Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: Bachelor's degree from four-year college or university, preferably in biology, microbiology, virology, animal science, or veterinary.
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Title: Senior Regulatory Affairs Specialist-Animal Tissue. Will report to the VP of Regulatory Affairs. Candidate will be responsible for regulatory activities related to Animal Tissue.
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Requirements: Master's degree in Regulatory Affairs, Engineering, Life Sciences, or closely related technical discipline (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or experience executing the complete lifecycle of product registrations before national and international regulatory agencies, including documenting internal processes for quality control, and coordinating post-market surveillance and reporting activities.
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Demonstrated ability to effectively integrate information from to varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs. Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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Strong regulatory affairs and governance requirements for healthcare. Thorough knowledge of state and local guidelines that govern regulatory processes for healthcare. Strong regulatory affairs and governance requirements for healthcare.
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This role will manage budgets and ensure that organizational goals are in keeping with conscientious, humane care of patients while complying with all federal and state guidelines. Gentiva Hospice is a member of the Gentiva family – an industry leader in hospice, palliative, home health, and personal home care.
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The SVP will set the direction of the Medical Affairs organization to ensure the right balance of in-house, partnered and outsourced expertise to meet Lantheus’ current and future requirements.
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Collaborate with internal teams, including R&D, engineering, manufacturing, regulatory affairs, and marketing, to drive program success. Ensure that program deliverable's meet quality standards and regulatory requirements.
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The job purpose and scope of the Scientific Communications Manager is to effectively communicate and proactively lead the dissemination of evidence generation activities from the clinical affairs organization.
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Provide overall company leadership and direction for worldwide Tecomet Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Reports To: Exec. V.P. Quality Assurance & Regulatory Affairs.
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Additionally, the Senior Director is responsible for directing the strategy for the Medical Science Liaison team and other members of the HQ PN Medical Affairs to ensure appropriate evidence generation and communication plans with healthcare professionals.
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The Senior Regulatory Affairs Program Lead is responsible for managing the collaboration with cross-functional stakeholders to ensure regulatory compliance is met. The Senior Regulatory Affairs Program Lead will oversee the technical liaison(s) between cross-functional departments and the Regulatory Affairs team.
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In this key strategic and technical leadership role, additional responsibilities will be to ensure collaboration with peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs, Operations, Medical Affairs and Regulatory functions as well as any other key stakeholders.
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regulatory affairs jobs in Tewksbury, MA
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