Regulatory Affairs Specialist

2 months ago

Somerset, United States Terumo Medical Corporation Full time

Job Summary:

This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements. Determining strategy and requirements within the position will vary in complexity based on scope and different regulatory markets. This position will prepare documents and/or submissions required to obtain clearance or approval from government agencies for commercial distribution of products worldwide. Serves as a liaison between Regulatory Agencies and Terumo Medical Corporation. Mistakes made in this area can be very costly, i.e., delays in product clearance or approval withdrawal of product from the marketplace, or enforcement of fines. Any of the above would have a major impact on the corporation.

Job Details:

Associate is responsible to follow requirements of applicable national and international regulations.

Analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.

Participates on product design teams and verifies compliance with design control requirements and procedures.

Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities.

Maintain documentation and a historical record for projects and provide management with updated product status.

Maintains current knowledge of Federal USA, Canadian, MDR and other International regulations pertaining to legal distribution of medical products. Stays abreast of Regulatory Agency updates including new policies and guidance’s.

Interact with production division, federal agencies, industry organizations, interdepartmentally and external departments at all levels with guidance.

Assists external customers by supplying materials and documentation for US and International product registrations as well as certification of appropriate US commercialization status.

Must make a proactive contribution to the overall Regulatory affairs department growth.

Participates in project performance team meetings on behalf of the business unit in order to provide ideas, methods or processes for unit/company performance improvement.

Develop regulatory strategies for new products with the guidance of Regulatory Management

Performs other job related duties as assigned.


Position Requirements:

Knowledge, Skills and Abilities (KSAs)

Strong organizational skills and time management skills

Knowledge of GLP/GMP requirements

Strong written and oral communication skills

Knowledge of FDA, EU, MHLW, TGA and other International requirements

Knowledge of product labeling requirements and standards

Advanced ability for independent work, teamwork, and decision making

Ability to make correct decisions based on interpretations of federal laws, which in many instances are very general in nature to accommodate a variety of industries. These interpretations are used for every aspect of the regulatory discipline from submissions to labeling issues.

Ability to analyze data received and prepare documentation for submissions for the purpose of obtaining clearance and or approval for product distribution.

Strong computer skills; MS Office, Adobe Acrobat


Background Experiences

Requires a minimum of a 4-year degree in engineering, life sciences, or similar discipline and one year of relevant experience or combination of equivalent education, background, experience and training

Experience in a medical device quality assurance environment preferred

Experience with 510(k)/IDE/PMA device submissions and/or other worldwide submissions and clearances preferred.

Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards preferred.

  • Regulatory Compliance Specialist

    6 days 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 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...

  • Senior Compliance and Regulatory Specialist

    2 months ago

    Somerset, United States Medvacon Life Sciences Full time

    Job DescriptionJob DescriptionSHIFT - MON-FRI 8AM-5PMThe 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...

  • Regulatory Compliance Expert

    3 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

    4 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),...

  • Legal Operations Specialist

    5 days 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...

  • Sr. QA Specialist

    2 weeks 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...

  • Validation Specialist for Computer Systems

    3 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...

  • Inventory Management Specialist

    24 hours ago

    Somerset, Massachusetts, United States Solar Cannabis Co. Full time

    Job DescriptionJob Title: Inventory Management SpecialistReports to: Assistant Inventory and Logistics ManagerJob Summary:We are seeking an experienced Inventory Management Specialist to join our team at Solar Cannabis Co. The successful candidate will be responsible for maintaining accurate records of plant inventory, ensuring compliance with state...

  • Computer Systems Validation Specialist

    3 months ago

    Somerset, United States LabVantage Full time

    A.Job Description ObjectiveLabVantage Professional Services (PSO) are expanding their team to provide an increased level of Computer Systems Validation (CSV) services and solutions, to address growing customer needs. As a key member of the LabVantage PSO team, the LIMS CSV Specialist is responsible for the delivery of CSV services which may include providing...

  • Cannabis Inventory Data Specialist

    2 days ago

    Somerset, Massachusetts, United States Solar Cannabis Co. Full time

    About the RoleSolar Cannabis Co. is seeking a highly skilled Cannabis Inventory Data Specialist to join our team. As a key member of our operations team, you will be responsible for ensuring the accuracy and integrity of our cannabis inventory data.Key ResponsibilitiesInventory Data Management: Collaborate with the Product Catalog Specialist to maintain a...

  • Commercial Quality Lead

    1 month ago

    Somerset, United States Medasource Full time

    Commercial Quality Lead6 month contract with extensionsHorsham, PA, Titusville, NJ, or Somerset, NJThe overall purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, documentation, internal audit/ supplier audits. Adheres to environmental policy, procedures, and supports department...

  • Clinical Laboratory Specialist

    2 weeks ago

    Somerset, Wisconsin, United States HealthPartners Full time

    Position Overview We are seeking a dedicated part-time Clinical Laboratory Specialist to become a vital member of our team. Role Responsibilities This role entails executing and interpreting intricate medical laboratory assessments and protocols that necessitate independent decision-making under supervision. Key Responsibilities: Receives, processes, and...

  • Client Care Specialist

    3 months ago

    Somerset, United States Addiction Recovery Care Full time

    Are you looking for the best place to work? Join Addiction Recovery Care, LLC (ARC) which was selected as one of the 2024 Best Places to Work in Kentucky by the Kentucky Chamber of Commerce, based on surveys of our employees! Are you passionate about serving in an environment of shared purpose and shared goals while driving the ARC mission and values to...

  • Client Care Specialist

    3 months ago

    Somerset, United States Addiction Recovery Care Full time

    Job DescriptionJob DescriptionAre you looking for the best place to work?  Join Addiction Recovery Care, LLC (ARC) which was selected as one of the 2024 Best Places to Work in Kentucky by the Kentucky Chamber of Commerce, based on surveys of our employees!Are you passionate about serving in an environment of shared purpose and shared goals while driving the...

  • Cannabis Inventory Data Specialist

    2 days ago

    Somerset, United States Solar Cannabis Co. Full time

    Job DescriptionJob DescriptionJOB TITLE: Cannabis Inventory Data SpecialistAUTHORITY & SUPERVISION: Reports to the Inventory and Logistics ManagerJOB DUTIES & RESPONSIBILITIES: Collaborate with the Product Catalog Specialist to ensure Operational teams maintain SKU creation form for introducing new products, as well as maintain a healthy SKU stack that...

  • Computer Systems Validation Expert

    4 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...

  • 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...

  • 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...