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The Senior Manager, Medical Writing will oversee post-market surveillance activities within the Clinical and Regulatory Affairs department. Partner with Regulatory Affairs in strategizing on regulatory pathways required for approved and new investigational devices and for indication expansion globally.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Review and approve all sales and marketing materials to ensure compliance with applicable regulatory requirements. Assess regulatory requirements and guidelines for countries in which Bay Materials markets and sells its products.
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Ensure that all applicable regulatory documentation requirements are met for each country. Communicate with regulatory agencies and reviewers to ask or answer questions. Review and revise regulatory documents related to company products.
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Ensures required quality procedures are established including CAPA, Non-Conforming Product, Risk Management, Post-market-surveillance, Purchasing Controls, Management Review, Traceability, Employee Controls, Post market management, Change Control, Advisory Notifications, Supplier compliance and others as coordinated within the Quality team and with other cross-functional departments.
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Develops and conducts training on key quality topics and best practices including Root Cause Investigations, CAPA investigations, Management Responsibility, GMP/GDP, Audit Readiness, and Validation.
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8+ years of experience producing technical documents, such as draft management review, KPIs at defined timeline, risk management for the quality system and formal procedures/ work instructions.
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Maintains the company Quality Management System to meet all applicable requirements for design & development, manufacturing and distribution for all Bay Materials products. Be site management representative.
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We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
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Manages Quality personnel(s) which may include individuals whose functions include Quality Engineering, Document Control, Incoming Inspection, Quality Assurance Testing, Calibration, Validation, and other related responsibilities.
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Masters degree in chemistry, biology, engineering, technology, or related science preferred. 8+ years of experience utilizing the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
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This role will evolve along with the company QMS as the company develops and commercializes new products and gains approval to market in various geographic markets. Bachelor’s degree in chemistry, biology, engineering, technology, or related science.
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From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others. Bay Materials strives to be the best provider of materials used for fabricating devices and treatments in the dental and orthodontic industry.
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regulatory affairs jobs Title: management Company: Abbott in WA, Ohio
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