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Ensures compliance of clinical studies with regulatory requirements, GCP guidance, and company policies. Monitors the regulatory status of clinical studies and mitigates GCP risks. You will be involved in all things Regulatory at Fluxergy, responsible for ensuring our processes, procedures, and product meet ISO13485 and FDA requirements.
$165,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Regulatory Affairs Director will also act as the Regulatory Responsible Person as defined by the EU MDR. Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience or a Regulatory Affairs MS or PhD with at least 7+ years of medical device regulatory affairs experience.
$230,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections.
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The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters.
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Represents regulatory affairs on product development and commercialization teams. Job Title: Regulatory Affairs SpecialistJob Responsibilities:This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.
$130,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Tracks timelines and documents milestone achievements for inclusion in regulatory submissions. Reviews documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
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Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files). Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
$80,000 - $120,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Prepares and oversees documentation packages for submission to global regulatory agencies. Minimum Experience: 3 years of experience in a regulatory role or related area. Assists with customer complaints/CAPA system.
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Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.
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For California, the base pay range for this position is $80,000 to $120,000 (highly experienced). Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
$120,000ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate effectively in a matrixed environment with Medical Affairs, Creative/CRM/Digital agencies, Media, Market Research, Analytics, Business Technology Solutions (BTS), Field Operations, and Medical/Regulatory/Compliance/Legal integrated business partners.
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Demonstrated excellence in developing global regulatory affairs strategies for medical products. The Regulatory Affairs Director is responsible for overseeing, developing, and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory clearance and approval for the Diality products.
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Lead or assist in projects to improve the efficiencies within the Regulatory Affairs team. A minimum of 10 years relevant regulatory experience required. Manage the version management process for the Vision Care business to ensure effective processes and accurate controls on market access.
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Since being founded the team has seen phenomenal and sustained organic growth, working across Medical Affairs, Publications, Promotional, Commercial and Regulatory spaces for their roster of blue-chip pharmaceutical companies and biotech's.
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Collaborates with Regulatory Affairs as an advisor for the complaints process. Knowledge of US and international regulatory requirements pertaining to medical devices preferred. Experience writing Post Market Surveillance and Clinical Evaluation Reports.
$138,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs in Irvine, Beech-grove, Indiana
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