Director of Quality and Regulatory Affairs
2 weeks ago
Company DescriptionJob DescriptionResponsibilitiesQuality Management:o Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.o Oversee internal and external audits to ensure compliance with regulatory requirements and internal policies.o Set and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture.Regulatory Affairs:o Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.o Prepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required.o Monitor and interpret regulatory developments and communicate implications to the executive team.Leadership and Collaboration:o Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.o Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.o Serve as the primary point of contact with regulatory bodies and notified bodies, managing all communications and inspections.Training and Education:o Develop and conduct training programs on quality and regulatory requirements for employees.o Ensure all staff are informed about the latest regulatory changes and quality standards.o Additional duties as assigned.QualificationsRequirementsA Bachelor's degree required.15 + years of Quality experience.A strong history of leadership skills with the ability to hire, mentor and guide Quality Engineering professionals.The successful candidate will come from the Medical Devices industry.Lean, Six Sigma, ASQ or similar certification beneficial.Experience with new product development and approval with original product submissions (CE Mark and FDA 510(k)).Experience with maintaining medical device quality systems and complaints, specifically ISO 13485.Additional InformationAll your information will be kept confidential according to EEO guidelines.
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Cleveland, Ohio, United States Research Group Inc Full timeJob Title: Director of Quality and Regulatory AffairsResearch Group Inc is seeking a highly experienced Director of Quality and Regulatory Affairs to lead our Quality and Regulatory Affairs team.Key Responsibilities:Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.Oversee...
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Director of Quality and Regulatory Affairs
4 weeks ago
Cleveland, Ohio, United States Centerline Biomedical Full timeJob SummaryThe Director of Quality and Regulatory Affairs will lead the development, implementation, and management of quality assurance and regulatory compliance programs at Centerline Biomedical. This role is crucial for ensuring that our products meet all necessary regulatory standards and that our quality management system (QMS) supports our commitment...
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Director of Quality
2 weeks ago
Cleveland, United States Centerline Biomedical Full timePosition Summary The Director of Quality & Regulatory Affairs is an Exempt/Full-Time position and will lead the development, implementation, and management of quality assurance and regulatory compliance programs. This role is crucial for ensuring that our products meet all necessary regulatory standards and that our quality management system (QMS) supports...
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Senior Quality and Regulatory Affairs Manager
3 weeks ago
Cleveland, Ohio, United States Research Group Inc Full timeQuality Management:We are seeking a highly skilled Director of Quality and Regulatory Affairs to lead our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards. This individual will oversee internal and external audits to ensure compliance with regulatory requirements and internal policies, setting and achieving QMS Key...
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Director of Quality and Regulatory Affairs
2 weeks ago
Cleveland, United States Research Group Inc Full timeCompany DescriptionJob DescriptionResponsibilitiesQuality Management:o Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.o Oversee internal and external audits to ensure compliance with regulatory requirements and internal policies.o Set and achieve QMS Key Performance...
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Senior Quality and Regulatory Affairs Manager
3 weeks ago
Cleveland, Ohio, United States Research Group Inc Full timeJob DescriptionAt Research Group Inc, we are seeking a highly skilled and experienced professional to lead our Quality and Regulatory Affairs team. The ideal candidate will have a strong background in quality management and regulatory affairs, with a proven track record of implementing and maintaining quality management systems (QMS) in accordance with ISO...
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Cleveland, Ohio, United States Centerline Biomedical Full timeJob SummaryThe Director of Quality Assurance and Regulatory Compliance will lead the development, implementation, and management of quality assurance and regulatory compliance programs at Centerline Biomedical. This role is crucial for ensuring that our products meet all necessary regulatory standards and that our quality management system (QMS) supports our...
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Director of Legal Affairs
4 weeks ago
Cleveland, Ohio, United States Cuyahoga County Juvenile Court Full timeJob Title: Director of Legal AffairsJob Summary:The Cuyahoga County Juvenile Court is seeking a highly qualified Director of Legal Affairs to lead its Legal Department. The successful candidate will be responsible for managing and directing the day-to-day operations of the department, which includes in-house counsel attorneys and support staff, a Records...
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Director of Quality Control Operations
4 weeks ago
Cleveland, Ohio, United States Abeona Full timeJob Title: Associate Director, Quality ControlAbeona is seeking an experienced Associate Director, Quality Control to lead our Quality Control activities associated with GMP production. The successful candidate will oversee the operation of our QC Microbiology and Transport functions, ensuring compliance with current FDA Guidelines, ICH, and foreign...
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Associate Director, Quality Control
2 weeks ago
Cleveland, United States Abeona Full timeThe Associate Director Quality Control (QC) will lead QC activities associated with the GMP production. Such products include Adeno-associated Viral Vectors (AAV) and Retroviral Cell Therapy Vectors. This position will oversee the operation of the QC Microbiology and Transport functions. The Director is responsible for supporting the QC testing, utility and...
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Cleveland, Ohio, United States Department of Veteran Affairs Full timeThe Department of Veteran Affairs is seeking a highly qualified candidate for the position of Physical Medicine and Rehabilitation Service Chief.The Louis Stokes VA Medical Center is a Level 1A facility with 17 locations of care and 594-bed tertiary medical center. As an academic hospital, it provides a full range of patient care services, with...
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Director of Quality Control
3 weeks ago
Cleveland, Ohio, United States Abeona Full timeJob SummaryThe Associate Director, Quality Control will lead QC activities associated with GMP production, including Adeno-associated Viral Vectors (AAV) and Retroviral Cell Therapy Vectors. This position will oversee the operation of QC Microbiology and Transport functions.Key ResponsibilitiesImplement and manage a GMP compliant laboratory control program...
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Senior Air Quality Consultant
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Cleveland, United States GHD Full timeGHD has a great opportunity for an Air Quality Permitting Director & a Senior Air Quality Consultant to join our Environmental team. Air Quality Permitting Director to be based out of any of our Mid-Continent Region offices.Air Quality Consultant can be based in most of our Northeast regional office locations.Air Quality Permitting Director...
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Licensed Practical Nurse
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Cleveland, Ohio, United States Saber Community Support and Development Office Full timeTransforming Lives through Compassionate CareSaber Community Support and Development Office is seeking a dedicated and experienced Clinical Services Director to lead our team of healthcare professionals in providing exceptional care to our residents. As a key member of our leadership team, you will be responsible for overseeing the clinical services...
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Hardware Quality Assurance Manager
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Director of Clinical Operations
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Cleveland, Ohio, United States Bridges Core Service Agency, Inc Full timeJob SummaryBridges Core Service Agency, Inc is seeking a highly skilled and experienced Clinical Director to lead our mental health programs. The ideal candidate will have a strong background in clinical operations and a passion for delivering high-quality care to our clients.The Clinical Director will be responsible for providing professional direction,...