Director of Quality and Regulatory Affairs

2 weeks ago


Cleveland Ohio, United States Research Group Full time
Job Description

Responsibilities

Quality 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.

  • Cleveland, United States Research Group Full time

    Job DescriptionJob DescriptionJob DescriptionResponsibilities Quality 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...


  • Cleveland, United States Research Group Full time

    Job DescriptionResponsibilities Quality 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...


  • Cleveland, United States Matrix Medical Devices Full time

    Company Description Matrix Medical Devices, on behalf of one of its Clients, is recruiting for a full-time Regulatory and Quality Manager in Cleveland, OH. Client is a rapidly growing small business, with multiple new product development programs. Role Description This is a full-time on-site role for a Regulatory and Quality Manager (Client) in Cleveland,...


  • Cleveland, United States Matrix Medical Devices Full time

    Company DescriptionMatrix Medical Devices, on behalf of one of its Clients, is recruiting for a full-time Regulatory and Quality Manager in Cleveland, OH. Client is a rapidly growing small business, with multiple new product development programs. Role DescriptionThis is a full-time on-site role for a Regulatory and Quality Manager (Client) in Cleveland, OH....


  • Cleveland, United States Matrix Medical Devices Full time

    Company DescriptionMatrix Medical Devices, on behalf of one of its Clients, is recruiting for a full-time Regulatory and Quality Manager in Cleveland, OH. Client is a rapidly growing small business, with multiple new product development programs. Role DescriptionThis is a full-time on-site role for a Regulatory and Quality Manager (Client) in Cleveland, OH....


  • Mason, Ohio, United States Voyage Foods Full time

    Who We AreWe're a food company using sustainable ingredients and thoughtful food science to replicate our favorite foods in ways that make them more affordable, less harmful, and really, truly just as delicious. We believe that in our best future, the best foods - the ones we love the most - will not just be earth-friendly, but also easy to afford and hard...


  • Cleveland, Ohio, United States Case Western Reserve University Full time

    Apply for Job Job ID 12799 Location Case Main Campus Full/Part Time Full-Time Regular/Temporary Regular Add to Favorite Jobs Email this Job Job DescriptionPOSITION OBJECTIVE The Administrative Director for Faculty Development and Emeriti Affairs supports Case Western Reserve Universitys faculty through the Office of Faculty Development. The office provides...


  • Cleveland, United States Cleveland Institute of Music Full time

    Job Summary The Academic and Student Affairs Coordinator provides administrative leadership within the Office of Academic and Student Affairs, whose mission is to provide a web of support and structure which empowers CIM's highly talented and ambitious students to thrive academically and artistically. Primary Duties and Responsibilities Provide executive...


  • Cleveland, United States Cleveland Institute of Music.. Full time

    Job DescriptionJob DescriptionJob SummaryThe Academic and Student Affairs Coordinator provides administrative leadership within the Office of Academic and Student Affairs, whose mission is to provide a web of support and structure which empowers CIM’s highly talented and ambitious students to thrive academically and artistically.Primary Duties and...


  • Cleveland, United States Medix™ Full time

    Job Title: Director of Manufacturing - IV DiagnosticsLocation: Cleveland OhioPosition Overview:Become the first Director of Manufacturing for a growing IV Diagnostics company that has recently gained FDA approval for on site Manufacturing, to combine with their current use of CMOs. You would be establishing the SOPs and standards of the site and would lead...


  • Cleveland, Ohio, United States Horizons Inc Full time

    Job DetailsJob Location Horizons Inc - Cleveland - Cleveland, OH Position Type Internship Description The Quality Assurance Internship will primarily focus on document control, upkeep, and maintenance of ongoing records and logs within our quality management system. As a Quality Assurance Intern, you will play a crucial role in ensuring that our organization...


  • Cleveland, Ohio, United States Case Western Reserve University Full time

    Apply for Job Job ID 12714 Location Case Main Campus Full/Part Time Full-Time Regular/Temporary Regular Add to Favorite Jobs Email this Job Job DescriptionPOSITION OBJECTIVE Lead administrative, curriculum development, and new student recruitment efforts for the Office of Undergraduate and Integrated Studies (UGIS). Collaborate with the associate dean and...


  • Cleveland, United States Medical Service Company Full time

    MEDICAL SERVICE COMPANY is a family owned and operated durable medical equipment and respiratory provider that's been in business for 70+ years!MSC is a 12 -Time recipient of the prestigious NorthCoast 99 Award as a Top Workplace to work - 2023! MSC is a two-time recipient of the prestigious National HME Excellence Award for Best Home Medical Equipment...


  • Cleveland, United States Medical Service Company Full time

    MEDICAL SERVICE COMPANY is a family owned and operated durable medical equipment and respiratory provider that's been in business for 70+ years!MSC is a 12 -Time recipient of the prestigious NorthCoast 99 Award as a Top Workplace to work - 2023! MSC is a two-time recipient of the prestigious National HME Excellence Award for Best Home Medical Equipment...


  • Cleveland, United States Case Western Reserve University Full time

    The successful applicant will demonstrate a track record of self-motivation and innovation in curricular or co-curricular programming, and flexible and creative problem-solving. The position requires enthusiasm and time to respond to students and colleagues when they need you, including answering calls and emails during off-hours, and participating in...


  • Cleveland, United States Case Western Reserve University Full time

    Case Western Reserve University Associate Director of Operations Cleveland , Ohio Apply Now Apply for JobJob ID12731LocationCase Main CampusFull/Part TimeFull-TimeRegular/TemporaryRegularAdd to Favorite JobsEmail this JobJob DescriptionPOSITION OBJECTIVEThe Associate Director of Operations is responsible for all aspects of the day-to-day operations within...


  • Cleveland, United States Howmet Aerospace Full time

    Job Summary:The Senior Director, Global Quality leads the Quality function for Howmet Wheel systems.  Howmet Wheel Systems is the proud manufacturer of nearly 5 million wheels per year, employing over 2,100 employees with locations in the United States, Hungary, China, Japan and elsewhere.  The person in this role is responsible for planning and...


  • Cleveland, Ohio, United States Howmet Aerospace Full time

    Job Summary:The Senior Director, Global Quality leads the Quality function for Howmet Wheel systems. Howmet Wheel Systems is the proud manufacturer of nearly 5 million wheels per year, employing over 2,100 employees with locations in the United States, Hungary, China, Japan and elsewhere. The person in this role is responsible for planning and implementing...


  • Cleveland, Ohio, United States Case Western Reserve University Full time

    Apply for Job Job ID 12731Location Case Main CampusFull/Part Time Full-TimeRegular/Temporary RegularAdd to Favorite Jobs Email this Job Job Description POSITION OBJECTIVEThe Associate Director of Operations is responsible for all aspects of the day-to-day operations within all non-athletic Division of Student Affairs Student Centers, this includes Thwing...


  • Cleveland, United States Howmet Aerospace Full time

    ResponsibilitiesJob Summary: The Senior Director, Global Quality leads the Quality function for Howmet Wheel systems. Howmet Wheel Systems is the proud manufacturer of nearly 5 million wheels per year, employing over 2,100 employees with locations in the United States, Hungary, China, Japan and elsewhere. The person in this role is responsible for planning...