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Quality And Regulatory Affairs Analyst Jobs

Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At United States
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Quality And Regulatory Affairs Analyst - Genetics Clinical Trials
By Mount Sinai Health System At United States
Maintaining a working knowledge and thorough understanding of federal and institutional regulations and polices relating to human subjects research
2+ years of experience in clinical research
Experience using electronic regulatory platforms a plus
Experience with industry-sponsored clinical trials preferred
Conducting internal auditing and monitoring activities to ensure compliance with study protocols and applicable regulations
Assisting investigators and clinical research coordinators in preparing for site monitoring visits and audits
Director Of Quality And Regulatory Affairs; Full Time; Days
By Mount Sinai At , New York, 10029 $140,000 - $230,584 a year
Responsible for supporting the management of an operating budget for the department.
Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.
Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.
Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.
Designs, develops, implements and evaluates quality improvement policies and procedures.
Develops and facilitates the use of data collection tools to support data analysis.
Quality And Regulatory Nurse
By Pappas Rehab Hosp for Children At , Canton, 02021 $83,172 - $138,787 a year
Experience in conducting training and educational sessions on quality, risk management, and patient safety topics for healthcare professionals
Provide training and education on quality, risk management, and performance improvement to staff, including new hire orientation.
Certification in Quality Management, Risk Management, or Patient Safety.
Experience with youth and young adults with physical disabilities.
Strong knowledge of accreditation standards and regulatory requirements, such as those set by the Joint Commission.
Education toward such a degree will be prorated on the basis of the proportion of the requirements actually completed.
Global Customer Experience Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , Westborough, Ma $106,692 - $149,366 a year
Experience and knowledge of all call center KPI & SL metrics.
Experience in driving change via business cases for transformation.
BA/BS in Business, communications. Equivalent years of experience in the business operation field and or medical device.
Experience of managing a critical path regarding customer complaints would be advantageous
Hands-on experience with service and support workflow tools such as ServiceNow, SFDC, Veeva, Oracle Zendesk.
Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , San Jose, 94088, Ca $115,026 - $161,036 a year
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
Senior Director Of Quality And Regulatory Affairs
By Goodall Brazier At Texas, United States
12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
Experience interacting with FDA and other global agencies
Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements
Experience leading a Quality Dept at a CDMO (preferred)
Regulatory Quality Analyst Jobs
By Foodchain Id Group Inc At , Remote
Good time management and organizational skills
Use project management systems (including JIRA, Zendesk, and Craqen) to track assignments, resolve client issues and improve regulatory data quality.
0 – 2 years of professional experience
Education or backgrounds that are most suitable are in international relations, political science, food safety or some sciences.
Good written and spoken communication skills
Determine root cause of issues presented by clients.
Regulatory And Quality Engineer
By Arobella Medical, LLC At Hopkins, MN, United States
Manage all aspects of regulatory affairs, including preparing and submitting regulatory submissions, reviewing labeling and advertising materials, and maintaining regulatory documentation.
3+ years of experience in regulatory affairs and quality engineering in the medical device industry.
Experience managing product submissions and interfacing with regulatory bodies.
Excellent problem-solving and analytical skills, with a keen attention to detail.
Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.
Lead quality control efforts, conducting product testing, analyzing data, and identifying areas for improvement in product design and manufacturing processes.
Vice President, Head Of Regulatory Affairs And Quality Assurance
By Scorpion Therapeutics At , Boston, 02114, Ma
Ensure the qualification, selection and management of vendors and contractors through a defined qualified process
Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs
Develop and manage Global Regulatory Affairs and QA budgets
Extensive experience leading, designing, writing and submission of regulatory filings and correspondence
Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities
Strong problem solving, critical thinking and analytical skills, required to make sound decisions
Regulatory And Quality Specialist
By Dr. Dennis Gross Skincare At New York City Metropolitan Area, United States
Advanced oral and written professional communication skills; agile and efficient time/project management.
Participate in pre-development assessment of formulations for corporate compliance, including SDS management, CARB, Proposition 65, ingredient selection, and nanotechnology.
2-4 Specialist years of cosmetic/personal care regulatory experience with a knowledge of cosmetic ingredients.
Help manage and track product liability claims, liaising with department heads & insurance companies.
Working knowledge of US cosmetic and OTC drug regulations.
Medical/510K experience & Quality Assurance experience are a plus.
Quality And Regulatory Manager
By Photo Diagnostic Systems At , Boxboro, 01719, Ma
Applying QMS to project management
o Customer service management and Complaint Handling
o Management Review (the non-boring version)
o Risk Management ISO 14791
applying QMS to project management
A working knowledge of ISO and Regulatory Compliance
Co-Op, Regulatory And Quality Affairs
By Alexion Pharmaceuticals,Inc. At , Boston, Ma
Organized individual with the ability to manage multiple priorities while maintaining high performance standards
Becoming familiar with laws, guidances, and regulatory requirements for drugs and combination products
Excellent written, verbal, and presentation skills and strong interpersonal skills
Working with regulatory subteams to support development and execution of regulatory strategies for compounds in development and/or for marketed products
Supporting submissions to relevant health authories across the globe
Researching and interpreting guidances and resources issued by health authorities and providing information to project teams to aid in strategic decisions
Quality Specialist - Rn (Regulatory Affairs)
By Stanford Health Care At , Palo Alto, 94304, Ca $64.52 - $85.49 an hour
Attends ongoing education as required for clinical database management.
Three (3) years of progressively responsible and directly related work experience
SHC Commitment to Providing an Exceptional Patient & Family Experience
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
Conducts comprehensive quality and patient safety studies, assessments, and evaluations of specific clinical activities for effectiveness
Conducts work independently and escalates system issues as necessary.
Vice President Of Quality And Regulatory Affairs
By Staffing Resource Group, Inc At Cranbury, NJ, United States
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
Project Management, Change Execution Management and Team Leadership experience in a Quality function a plus.
·Management of QA, QC, and Compliance team
·Demonstrated supervisory experience, leadership, and teamwork skills.
Ability to work independently as well as manage teams.
Strong quality mind and technical knowledge.
Director/ Senior Director, Quality Assurance And Regulatory Affairs
By Ginkgo Bioworks At , Remote $175,000 a year
Manage quality systems, and inform senior leadership in compliance with quality system requirements
Participate with leadership in setting strategic direction and developing the capabilities of the QA/RA team
Bachelor's degree and 10+ years of related experience
Strong knowledge of quality and regulatory standards pertaining to surveillance testing, approved diagnostics, and sample collection kits
High level of knowledge of business operations, objectives and strategies
Excellent problem-solving and decision-making skills
Associate Director, Quality Assurance & Regulatory Affairs
By Charles River Laboratories At , Northridge, 91325, Ca $137,900 - $186,500 a year
A minimum of 3 years supervisory or management experience required.
Coordinate and Manage Supplier Qualification and Vendor Qualification processes. Maintain all applicable documentation and records.
Process Improvement activities including developing statistical reports for tracking and trending quality system reports for reporting to executive management.
Working knowledge of federal and state requirements for human subject research protection, peripheral stem cell collections, and blood donor centers.
Support regulatory inspections and Supplier Qualification Audits, coordinate responses, maintain all applicable documentation and records.
Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance. Notify operations of regulatory changes.

Are you looking for an exciting opportunity to use your Quality and Regulatory Affairs expertise to make a difference? We are looking for a Quality and Regulatory Affairs Analyst to join our team and help us ensure that our products meet the highest standards of quality and regulatory compliance. You will be responsible for developing and maintaining quality and regulatory systems, conducting audits, and providing guidance to ensure compliance with applicable regulations. If you are an experienced professional with a passion for quality and regulatory affairs, this is the perfect job for you!

Overview Quality and Regulatory Affairs Analysts are responsible for ensuring that products and services meet all applicable regulatory requirements. They work with internal and external stakeholders to ensure that products and services are compliant with relevant laws, regulations, and standards. They also provide guidance and support to other departments in the organization to ensure that products and services meet the highest quality standards. Detailed Job Description Quality and Regulatory Affairs Analysts are responsible for ensuring that products and services meet all applicable regulatory requirements. They work with internal and external stakeholders to ensure that products and services are compliant with relevant laws, regulations, and standards. They also provide guidance and support to other departments in the organization to ensure that products and services meet the highest quality standards. Quality and Regulatory Affairs Analysts are responsible for developing and implementing quality assurance systems, conducting audits, and monitoring compliance with applicable regulations. They also review and analyze product and service data to identify potential areas of improvement. Job Skills Required
• Knowledge of applicable laws, regulations, and standards
• Ability to interpret and analyze data
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and problem-solving skills
• Proficiency in Microsoft Office applications
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in a related field
• Certification in quality assurance or regulatory affairs is preferred
Job Knowledge
• Knowledge of applicable laws, regulations, and standards
• Knowledge of quality assurance systems and processes
• Knowledge of product and service data analysis
• Knowledge of auditing techniques
Job Experience
• At least two years of experience in a related field
• Experience in developing and implementing quality assurance systems
• Experience in conducting audits and monitoring compliance
• Experience in analyzing product and service data
Job Responsibilities
• Develop and implement quality assurance systems
• Monitor compliance with applicable laws, regulations, and standards
• Conduct audits and review product and service data
• Provide guidance and support to other departments
• Identify potential areas of improvement
• Prepare reports and presentations for internal and external stakeholders