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Knowledge and understanding of regulatory affairs. 3+ years of experience in regulatory compliance and QA. Follow regulatory guidance to ensure standards and requirements are consistently met.
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The Regulatory Affairs & Documentation Specialist is responsible for formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations.
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This role will report directly to the VP of Regulatory Affairs and Quality, North America and will also work closely with the Complaints Manager located in North America. The position of Product Surveillance Specialist will support the reporting obligations and management of communication between the manfacturer, importers and regulatory authorities for all medical device complaint activities.
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The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization’s products.
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Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.
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This Regulatory Affairs Specialist II - APAC will work out of our Alameda, CA, location in the Diabetes Division. Provides support to Regulatory Affairs management when working towards resolution of compliance issues, assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
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Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH. Senior Regulatory Affairs Specialist. 5+ years of progressive experience in regulatory affairs required.
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Evaluate and address regulatory requirements to assist with business initiatives to enter into new markets in coordination with our Regulatory Affairs Specialist. We have been a pioneer in value-based care since 1991, offering deep clinical expertise, high-value specialty networks, behavioral health support, payment integrity solutions, and robust data analytics to generate the very best outcomes for patients, payers, and providers.
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With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule.
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The Specialist SRA leverages technical expertise for the execution of global raw material compliance, regulatory data management and digital transformation to unlock value and efficiency.
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The Director of Public Relations, Outreach, and Engagement (Marketing & Communications Specialist V) position exists to manage and implement the external affairs, media relations, public information, stakeholder engagement, outreach, and education functions of the division.
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The Principal Regulatory Affairs Specialist will be an individual contributor that will bring exceptional technical regulatory expertise. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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We are currently seeking a Senior Regulatory Affairs Specialist (CTA - Clinical Research Field. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.
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Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of relevant work experience) with 3 years of relevant experience in medical device regulatory affairs.
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Experience in compliance, quality, accreditation, government affairs/lobbying a plus. Reviews Provider Agreement, EOC/ Member Handbook, Provider Directory, marketing materials, and other contract reporting deliverables for compliance with contractual and regulatory requirements prior to submission.
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