Regulatory Compliance Specialist

3 weeks ago


Somerset, United States Terumo Medical Corporation Full time
Job Title: Quality Compliance Engineer II

Job Summary
The successful candidate will be responsible for maintaining the compliance of Terumo Medical Corporation's products and processes in the changing regulatory landscape.

Key Responsibilities:

  1. Support the management of Health Hazard Evaluations
  2. Track EU MDR deliverables
  3. Support cross-functional project teams with compliance-related decisions and interpretations
  4. Evaluate the impact of standard and regulation updates on existing product families and QMS processes
  5. Lead the evaluation of new and revised standards and regulations for impact to products and QMS processes
  6. Support the TMC health hazard and recall process
  7. Coordinate the HHE process by engaging stakeholders to ensure timely completion
  8. Support the drafting, planning, execution, and gathering of information for the Critical Action Committee meeting
  9. Execute the recall process by drafting regulatory submission documents, coordinating reviews, and working with affiliates and recall service providers
  10. Support cross-functional projects as a compliance SME
  11. Act as an independent reviewer on design control projects to ensure compliance with internal procedures and external standards and regulations
  12. Provide quality system and product guidance on updated regulations and standards
  13. Maintain expertise in quality management standards, software, and tools applicable to Terumo Medical Corporation
  14. Develop and maintain expertise in applicable quality regulations
  15. Drive Quality System or product enhancement projects associated with regulatory changes
  16. Review and draft proposals to implement changes to Quality System procedures and forms
  17. Assist and conduct internal audits to assess compliance with applicable regulations and standards
  18. Assist with third-party and regulatory audits
  19. Perform other job-related duties as assigned

Requirements:

  1. Bachelor's degree in Engineering or Scientific discipline
  2. 3-5 years of overall experience with at least 3 years of related experience in medical devices, diagnostics, pharmaceuticals, or other regulated industries
  3. Strong knowledge of FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements
  4. Ability to communicate and interact with all levels of the organization
  5. Strong interpersonal skills to provide coaching, training, and direction
  6. Strong proofreading and writing skills, as well as exemplary attention to detail
  7. Strong organizational and prioritization skills
  8. Ability to rapidly understand complex changes and pace work completion to meet company needs
  9. Technical knowledge to summarize and distill complex information
  10. Demonstrated initiative and ability to work independently while handling multiple tasks
  11. Strong computer knowledge, technical writing skills, and proofreading ability
  12. Demonstrated ability to work effectively with cross-functional teams

Why Terumo Medical Corporation?

Terumo Medical Corporation is a leading medical device company that values innovation, quality, and compliance. As a Quality Compliance Engineer II, you will be part of a dynamic team that is committed to delivering high-quality products and services that meet the changing needs of our customers and the regulatory landscape.

  • Somerset, New Jersey, United States Joulé Full time

    Job Title: Sr Compliance and Regulatory SpecialistAbout the Role:As a Sr Compliance and Regulatory Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products. You will be responsible for managing the supplier quality program, facilitating customer audits, and leading internal audits to ensure compliance...


  • Somerset, United States The Staffing Resource Group Inc Full time

    Job DescriptionSRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. Our innovative approach to identifying and qualifying talent is unique to the staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to...


  • Somerset, New Jersey, United States Adecco US, Inc. Full time

    Adecco US, Inc. is seeking a highly skilled Regulatory Compliance Expert to join their team in a pharmaceutical industry role. This position offers competitive compensation and the potential for full-time employment.As a Regulatory Compliance Expert, you will play a critical role in ensuring compliance with global regulations within the pharmaceutical...


  • Somerset, United States Adecco US, Inc. Full time

    Adecco US, Inc. is seeking a highly skilled Regulatory Compliance Expert to support our client's team in Somerset, NJ.This role offers competitive compensation ($53.00/hour) with the potential for full-time employment at the end of the 3-month contract period.As a Regulatory Compliance Expert, you will play a critical role in ensuring compliance with global...


  • Somerset, NJ, United States Joulé Full time

    Title: Sr. Compliance and Regulatory Specialist A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully. Location: Somerset NJ Schedule M-F 8:30 to 5:00pm On site daily Duration: 3 month contract to hire Education: * Bachelor's degree with at least 5+ years of experience working in...


  • Somerset, United States BCForward Full time

    Job DescriptionJob DescriptionBCforward is currently seeking a highly motivated Sr Compliance and Regulatory Specialist for an opportunity in Franklin Township, NJ 08873Position Description Job Title: Sr Compliance and Regulatory SpecialistLocation: Franklin Township, NJ 08873Pay Range: $50 - $53Duration - 3 MONTHS - TEMP TO HIREShift - MON-FRI 8AM-5PM Job...


  • Somerset, United States BCForward Full time

    Job DescriptionJob DescriptionBCforward is currently seeking a highly motivated Sr Compliance and Regulatory Specialist for an opportunity in Franklin Township, NJ 08873Position Description Job Title: Sr Compliance and Regulatory SpecialistLocation: Franklin Township, NJ 08873Pay Range: $50 - $53Duration - 3 MONTHS - TEMP TO HIREShift - MON-FRI 8AM-5PM Job...


  • Somerset, United States BCForward Full time

    Job DescriptionJob DescriptionBCforward is currently seeking a highly motivated Sr Compliance and Regulatory Specialist for an opportunity in Franklin Township, NJ 08873Position Description Job Title: Sr Compliance and Regulatory SpecialistLocation: Franklin Township, NJ 08873Pay Range: $50 - $53Duration - 3 MONTHS - TEMP TO HIREShift - MON-FRI 8AM-5PM Job...


  • Somerset, United States Planet Pharma Full time

    The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance and practical...


  • Somerset, United States Terumo Medical Corporation Full time

    Job SummaryThe Quality Compliance Specialist is responsible for ensuring the compliance of TMC's products and processes with regulatory requirements. This includes evaluating the impact of new and revised standards and regulations on existing product families and QMS processes.Key ResponsibilitiesSupport the management of Health Hazard Evaluations and track...


  • Somerset, United States Hydrogen Group Full time

    Job SummarySr. Director, Regulatory Affairs at Hydrogen GroupAbout the RoleThis is an individual contributor role that requires experience in regulatory affairs, with a focus on negotiating and communicating with the FDA.Key ResponsibilitiesSubmit regulatory dossiers for reformulations of a currently approved product, including administrative information,...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job SummaryThe Quality Compliance Engineer II is responsible for ensuring the compliance of TMC's products and processes in the changing regulatory landscape.This role involves supporting the management of Health Hazard Evaluations, tracking of EU MDR deliverables, and evaluating the impact of standard/regulation updates to existing product families and QMS...


  • Somerset, United States UPMC Life Changing Medicine Full time

    UPMC Life Changing Medicine is looking for a dedicated and compassionate Medical Support Specialist to support the daily operations of our Somerset Family Practice office.Responsibilities:Ensure seamless patient flow by checking schedules and organizing patient flow, accompanying patients to exam/procedure rooms, and assisting patients as needed with...


  • Somerset, United States IPS-Integrated Project Services, LLC Full time

    Job Description:At IPS, we are seeking a skilled Project Controls Specialist to join our team. In this role, you will be responsible for reviewing, coordinating, and summarizing the activities of cost control, planning and scheduling, document control, and estimating.You will support the Project Manager in the delivery of individual projects, focusing on...


  • Somerset, New Jersey, United States Aditi Consulting Full time

    Job Summary:Aditi Consulting is seeking a highly skilled Procurement Specialist to join our team. As a key member of our supply chain team, you will be responsible for maintaining the effectiveness of our quality system components, ensuring the timely supply of materials to support production, and resolving issues related to materials....

  • Contract Specialist

    4 weeks ago


    Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job Title: Contract SpecialistAt Terumo Medical Corporation, we are seeking a highly skilled Contract Specialist to join our team. As a Contract Specialist, you will be responsible for administering specific assigned stages of the Sales Contract Lifecycle, including drafting, reviewing, and analyzing the terms and conditions, pricing, and performance of...


  • Somerset, United States Home Depot Full time

    Home Depot - JobID: 8DE8F19E962D4EEE9FE0FC13A980325C [Loss Prevention / Security] As an Asset Protection Specialist at Home Depot, you'll: Prevent financial loss caused by theft and fraud; Support safety and environmental program compliance in your assigned store/multiple stores; Identify incidents of theft and fraud, review CCTV and exception reports,...


  • Somerset, New Jersey, United States Legend Biotech US Full time

    Job Title: Quality Systems IT SpecialistLegend Biotech US is seeking a highly skilled Quality Systems IT Specialist to join our US IT team based in Somerset, NJ.Job Summary:The Quality Systems IT Specialist will be responsible for maintaining various quality and validation applications, including Veeva vault, ComplianceWire, and DocuSign. This role requires...

  • Sr. QA Specialist

    3 months ago


    Somerset, United States On-Board Companies Full time

    On-Board Scientific is hiring a QA Specialist, Change Control/CAPA based out of the New Brunswick/Somerset, NJ area! For immediate consideration please send your resume to resumes@onboardusa.com Subject Line: Position Title and State you are located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing...


  • Somerset, United States Alternative Community Resource Programs Inc Full time

    Job SummaryAlternative Community Resource Programs Inc is seeking a highly motivated Mental Health Advocate Specialist to join our team. As a key member of our team, you will provide comprehensive support and services to adults and children struggling with serious mental illnesses or emotional disturbances. If you are passionate about promoting independence...