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Document Control Coordinates document and data control with the Director of Regulatory Affairs and Document Control Specialist, including creation / review / update of controlled documents and product specification.
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Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. Senior Director, Regulatory Affairs - Permanent - Remote.
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Primary Talent Partners has a 12 month contract opening for a Regulatory Affairs Specialist (MDR) with a Medical Device client of ours. Engage with cross-functional team focused on MDR product remediation and/or implementation to establish global regulatory strategies, participate in creation and review of key product development deliverables and author regulatory documents (EU MDR Technical Documents.
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The Senior Regulatory Specialist must be a key expert in regulatory and quality affairs both domestic and internally. The Senior Regulatory Specialist will be responsible for owning the regulatory and quality activities within the company.
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A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required. Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels.
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3-5 years’ experience supporting administration of complex research programs as a Study Coordinator, Clinical Research Nurse, Data Manager, Quality Assurance Specialist, Clinical Research Associate (CRA) or Regulatory Affairs Specialist for clinical research studies preferred.
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Collects regulatory documents and ensures that all documents and materials related to research projects are complete and current. Supports Director, Oncology Research Program, and Clinical Research Manager in contracting for specific projects, including industry and institution research contracts and confidentiality agreements.
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The ECR Specialist will provide responses to complaints and inquiries from Regulatory Agencies, Senior Executives, Government Affairs, and directly from customers. - The first level of complaints handled is from Senior Executives - Office of the President, The CEO, the Chairman's office, other Senior Corporate Executive's, and VIP complaints from Government Affairs.
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Senior Regulatory Affairs Specialist - Electrophysiology page is loaded Senior Regulatory Affairs Specialist - Electrophysiology Apply locations United States - Minnesota - Plymouth United States - Minnesota - St. Paul time type Full time posted on Posted 3 Days Ago job requisition id 31080311 Abbott is a global healthcare leader that helps people live more fully at all stages of life.
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The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate opening in Houston, TX for Senior Product Specialist – Ex Proof Global SPS.
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Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function. Role: Regulatory Specialist II.
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Regulatory Affairs Specialist IV. you will support Bio-Rad's commitment to quality and compliance by coordinating the Domestic and Intl Registration Requests as a Regulatory Specialist.
$107,200 - $147,400 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals.
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