Regulatory Compliance Specialist

2 weeks ago

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

Position Overview:

The Regulatory Compliance Specialist will assess and navigate the existing regulatory landscape for Terumo's medical devices and initiatives, outlining the necessary information and actions to fulfill compliance obligations. The complexity of regulatory strategies will vary based on the scope and diverse international markets. This role involves preparing essential documentation and submissions to secure the necessary approvals from regulatory bodies for the global distribution of products. The specialist will act as a critical liaison between Regulatory Agencies and Terumo Medical Corporation, as errors in this domain can lead to significant repercussions, including delays in product approvals or potential penalties.

Key Responsibilities:

  1. Ensure adherence to applicable national and international regulatory standards.
  2. Analyze incoming data and compile documentation for submissions aimed at achieving product clearance and approval.
  3. Engage with product design teams to verify compliance with established design control protocols.
  4. Identify and implement appropriate regulatory strategies for new product development initiatives, both domestically and internationally, while providing regulatory guidance to internal and external stakeholders.
  5. Maintain comprehensive documentation and historical records for projects, offering management regular updates on product status.
  6. Stay informed about current Federal USA, Canadian, MDR, and other international regulations relevant to the legal distribution of medical products, including updates from Regulatory Agencies.
  7. Collaborate with production teams, federal agencies, industry organizations, and various departments to provide regulatory guidance.
  8. Support external clients by supplying necessary materials and documentation for US and international product registrations, as well as certifying appropriate US commercialization status.
  9. Contribute proactively to the growth and development of the Regulatory Affairs department.
  10. Participate in project performance team meetings to offer insights and strategies for enhancing unit and company performance.
  11. Develop regulatory strategies for new products under the direction of Regulatory Management.
  12. Perform additional job-related duties as assigned.

Qualifications:

Knowledge, Skills, and Abilities:

  • Exceptional organizational and time management skills.
  • Understanding of GLP/GMP standards.
  • Strong written and verbal communication abilities.
  • Familiarity with FDA, EU, MHLW, TGA, and other international regulatory requirements.
  • Awareness of product labeling standards and requirements.
  • Advanced capability for independent work, teamwork, and sound decision-making.
  • Ability to interpret federal laws accurately, applying them to various aspects of regulatory practices.
  • Proficient in analyzing data and preparing documentation for regulatory submissions.
  • Strong computer proficiency, including MS Office and Adobe Acrobat.

Background Experience:

A minimum of a 4-year degree in engineering, life sciences, or a related field, coupled with one year of relevant experience or an equivalent combination of education and experience is required. Experience in a medical device quality assurance setting is preferred, along with familiarity with 510(k)/IDE/PMA submissions and other global regulatory clearances. Knowledge of FDA regulations, guidance documents, Medical Device Directives, Medical Device Regulations, ISO 14971, ISO 13485, and other international regulatory standards is also advantageous.

  • Regulatory Compliance Specialist

    1 week ago

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

    Position Overview:The Regulatory Compliance Specialist will assess the existing regulatory frameworks and devise strategies for Terumo's medical devices and initiatives, ensuring adherence to necessary regulations. The complexity of this role will fluctuate based on the scope of projects and the various regulatory environments involved. This position is...

  • Regulatory Compliance Expert

    7 days ago

    Somerset, New Jersey, United States System One Holdings, LLC Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the accuracy and reliability of our manufacturing processes.Key ResponsibilitiesDevelop and Implement Validation ProtocolsDesign and execute Installation...

  • Regulatory Compliance Expert

    7 days ago

    Somerset, New Jersey, United States System One Holdings, LLC Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the accuracy and reliability of our products.Key ResponsibilitiesDevelop and Implement Validation ProtocolsDesign and execute Installation Qualification (IQ),...

  • Regulatory Compliance Analyst

    2 weeks ago

    Somerset, New Jersey, United States IMS People Full time

    Job OverviewPosition: Regulatory Compliance AnalystLocation: Not specifiedDuration: Not specifiedShift: Not specifiedRole Summary:The Regulatory Compliance Analyst is expected to possess extensive knowledge of international regulations relevant to the pharmaceutical sector and their implications on production methodologies. The ideal candidate should be...

  • Manager of Healthcare Compliance

    2 weeks ago

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

    Position Overview:The Healthcare Compliance Specialist plays a crucial role in assisting the Director of Healthcare Compliance with various departmental projects aimed at fostering the development and execution of the Company Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:1. Collaborate with the Director to...

  • Compliance Manager for Healthcare Division

    7 days ago

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

    Job Summary:The Healthcare Compliance Manager supports the Director of Healthcare Compliance in driving departmental initiatives to develop and implement the Company's Ethics and Compliance Program across assigned Terumo Medical Corporation divisions.Key Responsibilities:Collaborate with the Director of Healthcare Compliance to develop and implement the...

  • Occupational Safety Compliance Specialist

    24 minutes ago

    Somerset, New Jersey, United States Paragon Staffing Full time

    Job SummaryParagon Staffing, LLC is a leading staffing agency that specializes in connecting job seekers with top employers who are seeking temporary, contract, or permanent positions.Due to our continued growth, we are seeking a highly skilled Health and Safety Compliance Officer to join our team!Key ResponsibilitiesEnsure that all health and safety...

  • Occupational Safety Compliance Specialist

    5 days ago

    Somerset, New Jersey, United States Paragon Staffing Full time

    Job Summary:Paragon Staffing, LLC is a leading staffing agency that specializes in connecting job seekers with top employers who are seeking temporary, contract, or permanent positions.We are seeking a highly skilled Occupational Safety Compliance Specialist to join our team! As a key member of our organization, you will be responsible for ensuring that all...

  • Healthcare Compliance Officer

    2 weeks ago

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

    Position Overview:The Healthcare Compliance Manager plays a pivotal role in assisting the Director of Healthcare Compliance with various departmental projects aimed at fostering the development and execution of the Company Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:1. Collaborate with the Director to enhance...

  • Compliance Manager for Healthcare

    2 weeks ago

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

    Position Overview:The Healthcare Compliance Manager plays a crucial role in assisting the Director of Healthcare Compliance with various departmental projects aimed at enhancing and executing the Company's Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:- Collaborate with the Director to develop compliance...

  • Senior EHS Compliance Specialist

    2 weeks ago

    Somerset, New Jersey, United States Catalent Inc Full time

    Position Overview:Catalent Inc. is seeking a Senior Environmental Health and Safety Specialist to join our team. This role is pivotal in addressing Environmental Health and Safety (EH&S) issues that arise from our operations, ensuring the protection of our assets and the integrity of our business. The selected candidate will be responsible for conducting...

  • Validation Specialist for Computer Systems

    7 days ago

    Somerset, New Jersey, United States LabVantage Full time

    Job SummaryLabVantage is seeking a highly skilled Computer Systems Validation Specialist to join our team. As a key member of our team, you will be responsible for delivering Computer Systems Validation (CSV) services to our clients.Key ResponsibilitiesValidation Consulting Services: Provide advisory services to LabVantage clients on CSV, creation of...

  • Manager / Sr Manager of Quality Assurance and Compliance

    7 days ago

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

    Job SummaryLegend Biotech US is seeking a highly skilled Manager/Sr. Manager, Quality Assurance and Compliance to join our Regulatory team in Somerset, NJ. As a key member of our team, you will be responsible for ensuring the quality and compliance of our nonclinical studies, maintaining a compliant quality system, and overseeing laboratory processes.Key...

  • Chemist - Analytical Specialist

    2 days ago

    Somerset, New Jersey, United States L Oreal USA Full time

    About the RoleWe are seeking a highly skilled Chemist - Analytical Specialist to join our team at L'Oreal USA. As an analytical chemist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesPerform Analytical Chemistry Testing: Conduct accurate and precise testing of samples to ensure compliance with...

  • Computer Systems Validation Expert

    7 days ago

    Somerset, New Jersey, United States LabVantage Full time

    Job SummaryLabVantage is seeking a highly skilled Computer Systems Validation Specialist to join our team. As a key member of our team, you will be responsible for delivering Computer Systems Validation (CSV) services to our clients.Key ResponsibilitiesValidation Consulting Services: Provide advisory services to LabVantage clients on CSV, creation of...

  • Legal Operations Specialist

    1 week ago

    Somerset, New Jersey, United States Terumo Aortic Full time

    Position Overview: The Legal Operations Specialist plays a crucial role in overseeing various legal affairs, including contracts, agreements, and regulatory filings, related to Terumo Aortic and its associated entities. This position involves supporting commercial activities, business development, corporate governance, intellectual property, and compliance...

  • Validation Engineer

    4 days ago

    Somerset, New Jersey, United States System One Holdings, LLC Full time

    About the Role:We are seeking a highly skilled Validation Engineer to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the validation of our manufacturing processes and equipment.Key Responsibilities:Validation Protocol Development: Develop and implement validation protocols,...

  • Product Packaging Specialist

    2 weeks ago

    Somerset, New Jersey, United States Scentbird Full time

    Product Packaging Specialist The Product Packaging Specialist is responsible for the design, evaluation, and implementation of innovative packaging solutions that align with the organization's product development initiatives. This role involves assessing and enhancing current packaging designs to meet evolving market demands. The individual will establish...

  • Environmental Project Specialist

    2 weeks ago

    Somerset, New Jersey, United States The Ladders Full time

    Job Title Environmental Project Specialist Job Type Regular Full Time Education Bachelor's Degree Category Scientific Position Overview This role is responsible for the design and execution of technical services to meet the needs of clients and project management. The position encompasses both fieldwork and office responsibilities, along with providing...

  • Contract Specialist

    1 week ago

    Somerset, New Jersey, United States Terumo Aortic Full time

    Job DescriptionTerumo Aortic is seeking a highly skilled Contract Specialist to join its Legal and Compliance Department. As a Contract Specialist, you will play a critical role in managing various commercial contracts, including agreements, filings, and negotiations, to support the company's business development, corporate governance, and healthcare...