Regulatory Compliance Specialist

6 days ago


North Haven, Connecticut, United States SysMind Tech Full time
Key Responsibilities
  • Develop and implement comprehensive quality control plans to ensure compliance with regulatory requirements
  • Maintain detailed knowledge of industry regulations, including FDA, GMP, ISO 13485, and ISO19471
  • Collaborate with engineers and technicians to design and implement quality-related improvements
  • Provide expert guidance on quality tools and methodologies, including Six Sigma and Lean Manufacturing
Requirements
  • Bachelor's Degree in engineering or technical field or equivalent combination of education and work experience
  • Minimum 3 years of related experience in a similar role
  • Demonstrated supervisory experience and strong project management skills
  • Advanced computer skills, including statistical/data analysis and report writing
Compensation

The estimated salary for this position is $120,000 - $160,000 per year, depending on qualifications and experience.


  • Technical Assistant

    3 weeks ago


    North Haven, Connecticut, United States HART United, Inc. Full time

    Company OverviewHART United, Inc. is a leading organization dedicated to providing top-notch services and support to our community.SalaryThe estimated salary for this position is $85,000 per year, commensurate with experience.Job DescriptionWe are seeking a highly skilled Technical Assistant - Regulatory Compliance Specialist to join our team. In this role,...


  • North Haven, Connecticut, United States Medtronic Full time

    Job Description:We are seeking a highly skilled Senior Medical Device Compliance Specialist to join our team at Medtronic.The successful candidate will be responsible for identifying and documenting appropriate complaint categories to ensure trend accuracy within the complaint database.Key Responsibilities:Writes investigation summaries based on technical...


  • North Haven, Connecticut, United States Medtronic Full time

    Job Description:MEDTRONIC IS SEEKING A MEDICAL DEVICE REGULATORY ANALYST TO JOIN OUR TEAM!The ideal candidate will have a strong background in medical device regulatory compliance and be able to work independently with minimal supervision.Key Responsibilities:Identify and document appropriate complaint categories to ensure trend accuracy within the complaint...


  • North Haven, Connecticut, United States Medtronic, plc Full time

    Job Description:We are seeking a skilled and detail-oriented Global Compliance Associate to join our team at Medtronic. In this role, you will play a critical part in ensuring compliance with regulatory requirements and maintaining accurate records.About the Role:The successful candidate will be responsible for identifying and documenting complaint...


  • North Haven, Connecticut, United States Three Point Solutions Full time

    Job Title: Associate Quality Systems SpecialistThis is an entry-level role at Three Point Solutions. As a Quality Assurance Specialist, you will be responsible for supporting the post-market Quality organization with management of scoping and bounding for post-market inquiries, reconciliation and disposition of product returns and product hold orders, and...


  • North Haven, Connecticut, United States Access Healthcare Full time

    About the JobWe are seeking a skilled Medical Oncology Nurse Specialist to join our team for a travel opportunity in New Jersey. This 13-week assignment requires a dedicated and compassionate RN with experience in oncology care.Job ResponsibilitiesProvide high-quality patient care in an oncology setting, focusing on symptom management, pain control, and...


  • New Haven, Connecticut, United States Langan Engineering and Environmental Services, Inc Full time

    Job Title: Environmental Permitting and Compliance Engineer, Scientist, or Project ManagerLangan seeks an experienced Environmental Permitting and Compliance Specialist for its New York region. This individual will manage industrial wastewater permitting and compliance projects.Responsibilities:Prepare permit applications (new, renewals, and modifications)...


  • New Haven, Connecticut, United States Mid Kansas Cooperative Full time

    Job OverviewMid Kansas Cooperative is seeking a highly skilled Agronomy Operations Specialist to join our team. In this role, you will oversee the operational functions of the agronomy department, ensuring seamless execution of tasks and exceptional customer service.About the RoleWe are looking for a detail-oriented individual with excellent communication...


  • North Haven, Connecticut, United States Entegee Full time

    Job Title: Automation Systems SpecialistAt Entegee, we specialize in custom automation projects and are a major player in the world of controls and robotic solutions globally.About the RoleWe're seeking an experienced Associate Quality Systems Specialist to support our engineering and quality system activities with knowledge of medical device regulations,...


  • North Haven, Connecticut, United States Entegee Full time

    Job Title: Associate Quality Systems SpecialistEntegee is seeking a highly skilled Associate Quality Systems Specialist to support our engineering and quality system activities. This individual will have in-depth knowledge of medical device regulations, including quality management and risk processes.Job Responsibilities:Ensure compliance with 21 CFR Part...


  • North Haven, Connecticut, United States ACES Full time

    About the RoleWe are seeking a skilled Behavior Intervention Specialist to join our team at ACES in North Haven, CT. As a key member of our staff, you will play a critical role in maintaining safety within our school environment and providing support to students with behavioral challenges.Job SummaryThe Behavior Intervention Specialist will assist in...

  • EHS Specialist

    6 days ago


    New Haven, Connecticut, United States Top Tier Reps LLC Full time

    About the RoleTop Tier Reps LLC seeks an EHS Specialist with 3-5 years of relevant experience to join their team in Boston, Connecticut, or New York office locations. The successful candidate will be responsible for providing expert advice on environmental, health, and safety matters, including:Compliance counselingPermittingRemedial mattersTransactional...


  • North Haven, Connecticut, United States Entegee Full time

    Job OverviewEntegee is seeking a skilled Associate Quality Systems Specialist to support engineering and quality system activities with a strong focus on medical device regulations.As a key member of our team, you will ensure compliance with 21 CFR Part 820 - Quality System Regulation and contribute to maintaining and enhancing medical device quality...


  • New Haven, Connecticut, United States Yale New Haven Health Full time

    About the RoleWe are seeking a skilled Cellular Therapy Quality Specialist to join our team at Yale New Haven Health. As a key member of our organization, you will play a vital role in ensuring the highest quality standards are met in our Cell Therapy Program.Job SummaryThis is a unique opportunity to work with a talented team dedicated to delivering...


  • North Haven, Connecticut, United States Entegee Full time

    Entegee is a leading provider of custom automation solutions, and we are currently seeking an experienced Packaging Engineer to lead validations of medical device packaging systems.This role will involve performing gap analyses, developing innovative packaging solutions in compliance with ISO standards, and ensuring compliance with industry practices.We...


  • North Haven, Connecticut, United States Entegee Full time

    Job OverviewWe are seeking a highly skilled Associate Quality Systems Specialist to join our team at Entegee, a leading custom automation projects company.CompensationThe salary for this position ranges from $30.00 to $35.00 per hour, providing a competitive income for the right candidate.Key ResponsibilitiesThis role involves supporting engineering tasks...


  • North Haven, Connecticut, United States Paul Mitchell Schools Full time

    Company Overview">Paul Mitchell Schools is a leading institution in the beauty industry with over one hundred schools nationwide.We are known for our unique culture, which fosters a collaborative and supportive learning environment.">Estimated Salary Range:$45,000 - $65,000 per year">About the Job">We are seeking an experienced Hair Education Specialist to...


  • North Haven, Connecticut, United States Entegee Full time

    Job Summary: We are seeking an experienced Senior Packaging Innovator to lead validations of medical device packaging systems, perform gap analyses, and develop innovative packaging solutions in compliance with ISO standards.About Entegee: As a leader in custom automation projects, we specialize in controls and robotic solutions globally. Our team is...


  • North Haven, Connecticut, United States Montowese Center for Health & Rehabilitation Full time

    Job Overview">Montowese Center for Health & Rehabilitation is seeking a skilled and compassionate Nursing Supervisor to lead our interdisciplinary team in delivering exceptional care to residents. As an Overnight Supervisor, you will be responsible for overseeing daily operations, ensuring compliance with nursing policies, and mentoring staff to maintain...


  • North Haven, Connecticut, United States LanceSoft, Inc. Full time

    Job Overview: LanceSoft, Inc. is seeking a Senior Reliability Engineer to join our team in North Haven, CT. The successful candidate will oversee and optimize the Issues Triage and Investigation (ITI) processes, improving process efficiency and communication between cross-functional teams.The ITI Process Manager will lead the development and implementation...