- DFMEA/PFMEA, Design Master Record, Design History Files, etc.)
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Regulatory Affairs Specialist
5 days ago
AtriCure, Inc. Cincinnati, United States Regular, Full time· Regulatory Affairs Specialist · Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA · Req #2095 · Wednesday, May 22, 2024 · AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 ...
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Regulatory Affairs Specialist
1 day ago
AtriCure, Inc. Cincinnati, United States Regular, Full time· Regulatory Affairs Specialist · Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA · Req #2100 · Wednesday, May 29, 2024 · AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 ...
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Experienced Regulatory Affairs Specialist
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Medpace Cincinnati, United StatesJob Summary: · Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Operations Associate to join our Regulatory Affairs team in Cincinnati. This position will work on a team to accomplish tasks and projects that are inst ...
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Medpace Cincinnati, United StatesJob Summary: · Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Operations Associate to join our Regulatory Affairs team in Cincinnati. This position will work on a team to accomplish tasks and projects that are inst ...
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Specialist - Regulatory Affairs - Allergy
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Cincinnati Children's Hospital Cincinnati, United StatesSUBFUNCTION DEFINITION: Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks.CCHMC SALARY GRADE:9REPRESENTATIVE RESPONSIBILITIES* ProtocolApply a comprehensive understanding of research reProtocolgulations, ethics and guidel ...
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Specialist - Regulatory Affairs - Allergy
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Cincinnati Children's Hospital Cincinnati, United StatesSUBFUNCTION DEFINITION: Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks. · CCHMC SALARY GRADE:9 · REPRESENTATIVE RESPONSIBILITIES · * Protocol · Apply a comprehensive understanding of research reProtocolgulations, e ...
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Specialist - Regulatory Affairs - Allergy
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cchmc Cincinnati, United States: · SUBFUNCTION DEFINITION: · Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks. · CCHMC SALARY GRADE: 9 · REPRESENTATIVE RESPONSIBILITIES · Protocol · Apply a comprehensive understanding of research reProtocolgulations ...
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Senior Regulatory Affairs Program Lead
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J&J Family of Companies Cincinnati, United StatesSenior Regulatory Affairs Program Lead W · Description · Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Program Lead , to be located in Cincinnati, Ohio; Raynham, MA; Raritan, NJ or Santa Clara, CA. · At Jo ...
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Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Cincinnati, United StatesSUMMARY: · The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Managemen ...
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Gateway Recruiting Cincinnati, United StatesSUMMARY: · The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Manageme ...
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Gateway Recruiting, INC. Cincinnati, United StatesJob Description · Job DescriptionSUMMARY: · The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Gr ...
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University of Cincinnati Cincinnati, United StatesCurrent UC employees must apply internally via SuccessFactors > · Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 35 ...
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University of Cincinnati Cincinnati, United States OTHERCurrent UC employees must apply internally via SuccessFactors > · Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 3 ...
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Director Of Safety
2 weeks ago
Actalent Cincinnati, United States Full timeLooking for a mid-level Safety specialist to be a part of consumer packaged goods company in downtown Cincinnati · Description: · Position Overview: · Oversees the entire safety program developing an inherent culture which makes safety the most important task we face each day. Wo ...
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Director Of Safety
2 weeks ago
Actalent Cincinnati, United States Full timeDescription: · Position Overview:Oversees the entire safety program developing an inherent culture which makes safety the most important task we face each day. Works to prevent workplace accidents and promotes health and safety awareness and education to fellow employees. Respons ...
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Quality Engineering CoOp Fall 2024
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Danaher Corporation Union, United StatesMammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, youre collaborating with a global team of engineers, designers, communicators, strat Quality Engineer, Engineer, Fa ...
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Quality Engineering CoOp Fall 2024
2 weeks ago
Mammotome Union, United StatesMammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you're collaborating with a global team of engineers, designers, communicators, strategists, and specialists to imp ...
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Quality Engineering CoOp Fall 2024
2 weeks ago
Danaher Corporation Union, United StatesMammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you're collaborating with a global team of engineers, designers, communicators, strategists, and specialists to imp ...
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Quality Assurance Systems Manager
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Smithfield Foods Union, United StatesIf you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.A great job-and a great future-awaits you at Smithfield Foods. We're an $18 billion U.S. food company with nearly 60,000 employees worldwide. We're looking for mo ...
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Registered Nurse
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U.S. Food and Drug Administration Union, United States** Registered Nurse (Patient Safety Manager)** · **Department of Veterans Affairs** · **Summary** · The Cincinnati, OH VA Medical Center is actively seeking a well-qualified Registered Nurse (RN) to function as a Patient Safety Manager. This position is located in the Quality ...
Director Quality Assurance and Regulatory Affairs - Union, United States - Gateway Recruiting
Description
SUMMARY:
The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR).
This role encompasses a wide range of responsibilities, including the development and implementation of quality system procedures, training associates on updated procedures, overseeing the Corrective and Preventive Action process (CAPA), evaluating product and process non-conformances, and providing support to production and inspection teams in addressing quality-related challenges.
The director demonstrates excellence in cross-functional collaboration and effectively collaborates with teams at all organizational levels. Together, we are committed to upholding the highest standards of product quality and regulatory compliance.ESSENTIAL FUNCTIONS:
General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws, and standards.
Responsible for the management of the Regulatory Affairs Processes, Registration, Non-Conformities, Product Recalls, and Medical Device Reporting (EUMDR).Act as Person Responsible for Regulatory Compliance (PRRC).Maintain an effective quality management system (QMS) to ensure the consistent delivery of high-quality products.
Define and monitor key quality performance metrics, ensuring continuous improvement in product quality.In charge of HIPAA-related activities, including Privacy Officer training for associates on updated and enhanced quality system procedures and instructionsOverseeing Vigilance and Post-Market Surveillance activitiesLeads and guides the quality and regulatory team, offering coaching to the purchasing staff and fostering collaboration between inspection personnel and other departments.
Manages staff selection, performance, development, and training to ensure team competencies align with business goals. Identifies department training needs and develops materials to support company objectives.Responsible for the quality interests and concerns of projects - assisting design controls (Design Inputs/Outputs, Design Verification and Validation, Design, and Process Risk Management
Responsible for the System Computer Software Validation in compliance of the standards and regulations.
Establishes and maintains the Company's System Procedures for regulatory compliance.
Manages incident reporting and adverse event recalls.
Responsible for Establishment Registration & Device Listing of class I and II Medical DevicesOversees Risk Management for Medical Devices according to ISO 14971Promotes the development of Quality Competencies and Quality Awareness throughout the organization.
KNOWLEDGE, SKILLS, AND ABILITIES:
Bachelor's degree in a relevant field or Engineering; advanced degree preferred with greater than 10 years of experience in the creation and Management of Quality Systems.3+ years of related experience in the Medical Device FDA-regulated industry to include product/process validation and solving technical problems.
Experience working as a Quality Engineer or Manager in a manufacturing environment Competent in FDA QSR, ISO 13485, and ISO9001, ISO14971, & EUMDR requirements.
Strong knowledge of FDA regulations and international regulatory requirements.Excellent leadership and team management skills.
Strong analytical and problem-solving abilities.
Demonstrated ability to work collaboratively across departments.
Skilled auditor with knowledge of FDA, ISO13485, and EUMDR requirements. Ability to read and interpret drawings and design specifications.
Proficient in technical writing skills and communications.
