Senior Quality and Regulatory Affairs Manager
4 weeks ago
Quality 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 Performance Indicators (KPIs) to drive a culture of quality and compliance.
Regulatory Affairs:
The successful candidate will develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements. They will prepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required, and monitor and interpret regulatory developments to communicate implications to the executive team.
Leadership and Collaboration:
This is a leadership role that requires the ability to lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization. The individual will 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.
Training and Education:
The Director of Quality and Regulatory Affairs will develop and conduct training programs on quality and regulatory requirements for employees, ensuring all staff are informed about the latest regulatory changes and quality standards. A Bachelor's degree is required, and 15+ years of Quality experience is necessary. A strong history of leadership skills, with the ability to hire, mentor, and guide Quality Engineering professionals, is essential. Experience with new product development and approval, with original product submissions (CE Mark and FDA 510(k)), is beneficial. Experience with maintaining medical device quality systems and complaints, specifically ISO 13485, is also required.
-
Senior Quality and Regulatory Affairs Manager
4 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...
-
Director of Quality and Regulatory Affairs
1 month 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...
-
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...
-
Cleveland, Ohio, United States Department of Veteran Affairs Full timeJob Opportunity: Service Chief of Physical Medicine and RehabilitationThe Department of Veteran Affairs is seeking a highly qualified candidate to fill the position of Service Chief of Physical Medicine and Rehabilitation. As a seasoned professional, you will be responsible for maintaining full responsibility for all professional, management, and...
-
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...
-
Medical Support Assistant
4 weeks ago
Cleveland, Ohio, United States Veterans Affairs, Veterans Health Administration Full timeJob SummaryThe Veterans Affairs, Veterans Health Administration is seeking a Medical Support Assistant (Advanced) to join our team. This role will function in the Physical Medicine and Rehabilitation Service (PM&RS) and will be responsible for scheduling, tracking, and monitoring consults and follow-up appointments.Key ResponsibilitiesScreen, track, and...
-
Cleveland, Ohio, United States Harmony Roze Staffing & Recruiting Full timeJob Title: Senior Healthcare Technology Management ExecutiveJob Summary:We are seeking a Senior Healthcare Technology Management Executive to join our team at Harmony Roze Staffing & Recruiting. As a key member of our organization, you will be responsible for leading our Healthcare Technology Management team and ensuring the delivery of high-quality services...
-
Senior Quality Assurance Engineer
4 weeks ago
Cleveland, Ohio, United States Integrated Talent Strategies Full timeJob Title: Senior Quality Assurance EngineerAbout the Role:Integrated Talent Strategies (ITS) is seeking a Senior Quality Assurance Engineer to work in the Cleveland, Ohio area. This is a direct hire position that offers a variety of great benefits, including health insurance, 401(k), and paid time off.Key Responsibilities:Implement innovative ideas,...
-
Senior Manager of Accounting
1 month ago
Cleveland, Ohio, United States ACCEL Schools Full timeJob SummaryACCEL Schools is seeking a highly skilled Senior Manager of Accounting to oversee the day-to-day accounting, grant funding, and monthly financial reporting. The ideal candidate will have a strong background in accounting, financial analysis, and management, with a minimum of 10 years of experience in increasingly responsible management...
-
Student Affairs Assistant
1 month ago
Cleveland, Ohio, United States Tri C Company Inc Full timeJob SummaryAs a Student Affairs Assistant at Tri C Company Inc, you will provide basic clerical support and perform various office tasks to ensure the smooth operation of the department. You will also provide general customer service to internal and external stakeholders.Key Responsibilities* Assist with departmental assignments as directed* Provide support...
-
LPN Medication Care Manager
4 weeks ago
Cleveland, Ohio, United States Sunrise Senior Living Full timeJob Title: LPN Medication Care ManagerSunrise Senior Living is seeking a highly skilled LPN Medication Care Manager to join our team. As a Medication Care Manager, you will be responsible for providing high-quality care and services to our residents by administering medication and treatments in a safe and organized manner.Responsibilities:Administer...
-
Senior Financial Manager
4 weeks ago
Cleveland, Ohio, United States E3 Recruiting Full timeJob OverviewWe are seeking a highly skilled Senior Financial Manager to lead our accounting team and drive financial stability and accuracy within our organization.This pivotal role involves maintaining the financial health of our company, ensuring compliance with regulatory standards, and collaborating with diverse teams to achieve business objectives.Key...
-
Travel Application Specialist
4 weeks ago
Cleveland, Ohio, United States Cleveland Clinic Full timeJob SummaryAs a Senior Quality Improvement Specialist at Cleveland Clinic, you will play a critical role in directing safety, quality, and experience work across an Enterprise service line or submarket. You will demonstrate expert-level competencies in several domains, including quality review and accountability, patient safety, quality leadership and...
-
Senior Portfolio Analytics Specialist
4 weeks ago
Cleveland, Ohio, United States PNC Bank NA Full timeJob SummaryWe are seeking a highly skilled Senior Portfolio Analytics Specialist to join our team at PNC Bank NA. As a key member of our analytics team, you will be responsible for providing financial and regulatory reporting and analyses to maintain adequate controls over the financial and regulatory reporting processes.Key ResponsibilitiesDevelop and...
-
Senior Project Manager
4 weeks ago
Cleveland, Ohio, United States Forsyth Barnes Full timeJob Title: Senior Project ManagerJob Type: Full-Time – HybridSalary: up to $130,000 + bonus + benefitsLocation: Cleveland, OH – 3 days on-site/2 days remoteSector: RetailOverview:Forsyth Barnes is seeking a skilled Senior Project Manager to lead the delivery of high-quality information systems-specific projects. As a key member of our team, you will...
-
Contract Negotiation Specialist
4 weeks ago
Cleveland, Ohio, United States The Center for Health Affairs and CHAMPS Healthcare Full timeJob OverviewThe Center for Health Affairs and CHAMPS Healthcare is seeking a skilled Contract Negotiation Specialist to join our contracting team. As a key member of our team, you will play a vital role in negotiating, initiating, and managing vendor agreements and contracts.Key Responsibilities:Negotiate and manage vendor agreements and contracts to ensure...
-
Senior District Manager Healthcare Technology
1 month ago
Cleveland, Ohio, United States SpeakEZ Virtual Solutions LLC Full timeJob OverviewOur client, a leading healthcare organization, is seeking a seasoned professional to serve as the Senior District Manager of Healthcare Technology Management. This critical role will oversee the delivery of exceptional HTM services, ensuring the highest level of patient care and safety.Key ResponsibilitiesProvide strategic leadership to the HTM...
-
Cleveland, Ohio, United States Veterans Affairs, Veterans Health Administration Full timeJob SummaryThis position is a key leadership role within the Physical Medicine and Rehabilitation Service. The successful candidate will be responsible for overseeing the service's clinical programs, research initiatives, and administrative functions. Responsibilities- Develop and maintain annual budgets for service resources, staffing, training, and...
-
Pharmacy Technician Regulatory Specialist
4 weeks ago
Cleveland, Ohio, United States Cleveland Clinic Full timePharmacy Technician Regulatory RoleCleveland Clinic's Main Campus is seeking a skilled Pharmacy Technician Regulatory to join our team. As a key member of our Department of Pharmacy, you will play a vital role in developing strategies for drug diversion prevention and ensuring compliance with regulatory requirements.Key Responsibilities: Assist department...
-
Regulatory Compliance Specialist
1 week ago
Cleveland, Ohio, United States Pace® Life Sciences Full timeJob OverviewPace Life Sciences is seeking a highly skilled Regulatory Compliance Specialist to join our team.About the Role:Provide regulatory compliance expertise in the chemical industry, ensuring adherence to relevant laws and regulations.Develop and implement effective compliance programs, policies, and procedures to mitigate risks and ensure regulatory...