Current jobs related to Regulatory Affairs Specialist Lead - Shannon - Mason Alexander

  • Regulatory Affairs Specialist

    2 days ago

    Shannon, Ireland Atlantic Aviation Group Full time

    Compliance and Regulatory Affairs Specialist - AviationWe are seeking an experienced Compliance and Regulatory Affairs Specialist to join our team as a Regulatory Affairs Specialist - Aviation. In this role, you will be responsible for ensuring compliance with EASA regulations and other relevant national aviation authorities.The ideal candidate will have a...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Shannon, Ireland Sigmar Recruitment Full time

    About Your New Employer:This employer is a strategic partner for small to large companies, physicians, universities and government-funded projects to advance the development of life-changing medical technologies.The Senior Regulatory Affairs Specialist will provide support to the functional project teams on Biological Evaluations for new and existing...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Shannon, Ireland Sigmar Recruitment Full time

    The Senior Regulatory Affairs Specialist will provide support to the functional project teams on Biological Evaluations for new and existing products/indications. The role will involve implementing biological evaluation plans and reports to meet business targets, participating and interacting with project groups ensuring MDD/MDR Compliance, assisting with...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Shannon, Ireland Mason Alexander Full time

    A cutting-edge Medtech leader based in Co. Clare are looking to hire a Senior Regulatory Affairs Specialist who will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products. This role involves collaborating with cross-functional teams to...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Shannon, Ireland Mason Alexander Full time

    A cutting-edge Medtech leader based in Co. Clare are looking to hire a Senior Regulatory Affairs Specialist who will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products. This role involves collaborating with cross-functional teams to...

  • Regulatory Affairs Coordinator

    7 days ago

    Shannon, Ireland Lucida Search Partners Full time

    Job Overview: Regulatory Affairs CoordinatorLucida Search Partners is seeking a skilled Regulatory Affairs Coordinator to join its team. This role involves supporting the legal department in managing legal documentation, assisting with compliance processes, and providing administrative support to the legal, company secretarial, and insurance teams.Main...

  • Regulatory Compliance Specialist

    5 hours ago

    Shannon, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

    Role Summary:The Senior Quality Assurance Director at Sterling Engineering Ltd - Ireland & Europe will be responsible for leading the company's quality strategy, ensuring compliance with regulatory requirements and optimizing processes for continuous improvement. This role requires a strong understanding of quality standards, methodologies, and best...

  • Quality Assurance and Compliance Manager

    2 days ago

    Shannon, Ireland Atlantic Aviation Group Full time

    Aviation Compliance and Safety ExpertWe are seeking an experienced Aviation Compliance and Safety Expert to join our team as a Regulatory Affairs Specialist - Aviation. In this role, you will be responsible for ensuring compliance with EASA regulations and other relevant national aviation authorities, and identifying opportunities for continuous...

  • Head of Regulatory Affairs and Compliance

    6 days ago

    Shannon, Ireland Zimmer Biomet Full time

    **Responsibilities**The ideal candidate will possess professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all company disciplines and business units. Key responsibilities include:Developing and implementing quality system strategies and objectivesProviding leadership and guidance to Quality,...

  • Radio Frequency Design Specialist

    7 days ago

    Shannon, Ireland Ei Electronics Gmbh Full time

    We are looking for a talented Radio Frequency Design Specialist to join our team at Ei Electronics. In this role, you will be responsible for designing and developing Radio Frequency (RF) systems and devices that meet company and customer requirements.The ideal candidate will have a strong background in RF engineering and experience with design tools and...

  • Aviation Maintenance Specialist

    5 days ago

    Shannon, Ireland Ryanair Full time

    PAM Ireland Ltd is seeking a highly skilled Aviation Maintenance Specialist to join our team at Shannon Airport.This dynamic role provides an opportunity to work in a fast-paced, evolving environment, offering significant growth potential in the aviation industry.Key Responsibilities:Ensure all maintenance tasks are performed in compliance with regulatory...

  • Manufacturing Operations Lead

    3 days ago

    Shannon, Ireland Aerogen Ltd Full time

    About AerogenAerogen is a leading provider of innovative solutions in acute care aerosol drug delivery, with a strong presence globally. Headquartered in Galway, we strive to make a significant impact in patients' lives daily.Job RoleThe Production Supervisor will play a pivotal role in managing and motivating Process Specialists, production operators, and...

  • Senior Quality Assurance Director

    9 hours ago

    Shannon, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

    Job Overview:Sterling Engineering Ltd - Ireland & Europe is seeking a Regulatory Compliance Specialist to lead our client's quality strategy, ensuring compliance with regulatory requirements and optimizing processes for continuous improvement. As a key member of our quality team, you will be responsible for developing and implementing quality standards,...

  • Freight Operations Specialist

    5 days ago

    Shannon, Ireland TN Ireland Full time

    Job Summary:We are looking for a skilled Freight Operations Specialist to join our team at TN Ireland. This role involves coordinating the movement of freight and information within our operational system.Main Duties and Responsibilities:Coordinating the movement of freight and informationTracking and tracing files and reporting information to customersUsing...

  • Medical Device Operations Specialist

    5 days ago

    Shannon, Ireland TN Ireland Full time

    At TN Ireland, we are seeking a highly skilled Medical Device Operations Specialist to join our team in Shannon, Co Clare. Our client is a renowned medical device manufacturing company that requires experienced professionals like you to ensure the highest quality standards.The ideal candidate will have extensive experience working in a medical device...

  • Aircraft Maintenance Lead

    5 days ago

    Shannon, Ireland Ryanair Full time

    PAM Ireland Ltd is recruiting an Aircraft Maintenance Lead to join our team at Shannon Airport.This challenging role involves overseeing the maintenance of a fleet of 600+ aircraft for one of the world's largest and most successful airlines.Responsibilities:Oversee the execution of maintenance tasks, ensuring compliance with regulatory requirements and...

  • Sustainability and Compliance Lead

    22 hours ago

    Shannon, Ireland Aerogen Ltd Full time

    About AerogenAerogen is a leading medical technology company dedicated to transforming patient lives through innovative aerosol drug delivery solutions. Headquartered in Galway, Ireland, we have a global presence with offices around the world.We are proud to have been recognized through multiple MedTech awards and have won the Zenith award for Respiratory...

  • Warehouse and Freight Team Lead

    5 days ago

    Shannon, Ireland TN Ireland Full time

    Job Description:The Warehouse and Freight Team Lead will be responsible for managing the movement of freight and information within our operational system. This includes tracking and tracing files and reporting information to customers.Main Duties and Responsibilities:Managing the movement of freight and informationTracking and tracing files and reporting...

  • Wireless Communications Specialist

    7 days ago

    Shannon, Ireland Ei Electronics GmbH Full time

    Ei Electronics GmbH is a leading provider of innovative RF solutions, serving customers worldwide. As an RF Engineer on our team, you'll have the opportunity to work on exciting projects that push the boundaries of wireless communication technology.Your primary responsibility will be to design, develop, and implement RF systems and devices that meet our...

  • Production Management Specialist

    3 days ago

    Shannon, Ireland Aerogen Ltd Full time

    About AerogenAerogen Ltd is a global leader in acute care aerosol drug delivery, renowned for its innovative solutions and commitment to excellence. With headquarters in Galway and offices worldwide, we pride ourselves on making a difference in patients' lives every day.Job OverviewWe are seeking a highly skilled Production Supervisor to join our team. As a...

Regulatory Affairs Specialist Lead

2 weeks ago

Shannon, Ireland Mason Alexander Full time

Key Responsibilities

The successful candidate will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.

This role involves collaborating with cross-functional teams to ensure compliance with applicable regulations and standards while facilitating product commercialization and market access.

Biological Evaluation Specific Responsibilities

  • Support/prepare biological evaluation plans and reports for marketing, regulatory affairs, clinical affairs design review, post-market surveillance, and reimbursement purposes.
  • Coordinate multiple projects at one time and provide regular reports to regulatory management, clinical affairs, and others as required.
  • Work closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators.
  • Maintain an excellent understanding of the global medical device regulations especially with respect to Bio-compatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories, and methodologies and applying gained expertise within safety processes.
  • Coordination with external biological laboratories on testing required and compilation of requirements to conduct same for example: samples, quotes, critical review of protocols, reports, etc.
  • Communication with consultant/toxicologists/peer review within the client as necessary.
  • Design and conduct literature searches on products, specific surgical indications, outcomes, or other areas.
  • A primary contact for biological working groups/training going forward.
  • Support pre-clinical and clinical activities as required.