Global Regulatory Lead

2 weeks ago


Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time
Regulatory Affairs Specialist Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will be responsible for managing technical documentation, conducting global regulatory impact assessments, and providing regulatory support for R&D projects. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and develop strategic plans to mitigate potential risks.

Key Skills:

• Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment.
• Minimum of 3 years' experience in R&D, QA/RA, Validations
• 3-4 years' experience in Risk, Clinical, and Biocompatibility – an advantage
• Excellent technical writing experience within a medical device environment - essential
• Attention to detail and accuracy – essential
• Fluent in English, both written and oral - essential
• Ability to work well under deadlines and pressure
• Problem-solving skills for developing creative solutions and meeting objectives are required.

Benefits:

We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off. Additionally, we provide opportunities for career growth and professional development.

  • Tullamore, Uíbh Fhailí, Ireland Teleflex Full time

    We are committed to improving the health and quality of people's lives at Teleflex. As a leading provider of medical technologies, we offer a diverse portfolio with solutions in various therapy areas. Our vision is to become the most trusted partner in healthcare.About the RoleWe are seeking a highly skilled Regulatory Affairs Professional to join our team...


  • Tullamore, Uíbh Fhailí, Ireland Quanta Consultancy Services Ltd Full time

    About Quanta Consultancy Services Ltd">We are a renowned supplier of sterile injectable pharmaceutical products, serving clients in regulated and semi-regulated markets worldwide.">Role Overview:">This is an exceptional opportunity to leverage your expertise in Regulatory Affairs to drive business growth and success.">Key Responsibilities:">">This role...


  • Tullamore, Uíbh Fhailí, Ireland Quanta Consultancy Services Ltd Full time

    About Quanta Consultancy Services Ltd">We are a global supplier of sterile injectable pharmaceutical products, with a portfolio of sterile injectable drugs and a robust pipeline of products in development for regulated and semi-regulated markets.">Responsibilities:">">The ability to understand HPRA BoH requirements for hosting a market authorisation is...


  • Tullamore, Uíbh Fhailí, Ireland TN Ireland Full time

    About the RoleWe are seeking a highly experienced and motivated Quality Manager to join our team at STERIS. As a key member of our leadership team, you will play a critical role in driving quality improvement and ensuring compliance with regulatory standards.The successful candidate will have a strong background in quality management, with experience working...


  • Tullamore, Uíbh Fhailí, Ireland Quanta Consultancy Services Ltd Full time

    About Quanta Consultancy Services Ltd">We are a leading provider of sterile injectable pharmaceutical products, with a strong presence in regulated and semi-regulated markets.">Key Responsibilities:">">This role requires a deep understanding of HPRA BoH requirements for hosting a market authorisation.">You will be responsible for acting as a Responsible...


  • Tullamore, Uíbh Fhailí, Ireland Teleflex Full time

    At Teleflex, we are driven by our purpose to improve the health and quality of people's lives. Our vision is to become the most trusted partner in healthcare, offering a diverse portfolio with solutions in various therapy areas.Job DescriptionWe are seeking a highly skilled Sr. Regulatory Affairs Associate to support our regulatory activities in the EMEA...


  • Tullamore, Uíbh Fhailí, Ireland Vectura Group plc Full time

    The Vectura Group plc is seeking a highly experienced Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative.Key...

  • Bioassay Analyst

    24 hours ago


    Tullamore, Uíbh Fhailí, Ireland Quanta Consultancy Services Ltd Full time

    About Our ClientOur client is a Centre of Excellence for the development and production of veterinary vaccines, with a commitment to delivering high-quality products and services to their clients.About the JobWe are seeking a highly skilled QC Bioassay Analyst to join our client's team. As a key member of the bioanalytical department, you will be responsible...


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    Senior Regulatory Affairs SpecialistOur client, a Medical Device Multinational, currently seeks a Senior Regulatory Specialist to join their team. The Senior Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and...


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    Job Description:The Senior Regulatory Affairs Specialist will be responsible for developing strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. This role will also involve mentoring and development of staff members as part of...


  • Tullamore, Uíbh Fhailí, Ireland TN Ireland Full time

    Job Summary">This is a unique opportunity to join our Global Manufacturing Technology group in Tullamore as a Technical Support Specialist for Pharmaceutical Manufacturing.">The successful candidate will provide hands-on technical support for manufacturing process activities, investigate and resolve process deviations, and ensure compliance with cGMP...


  • Tullamore, Uíbh Fhailí, Ireland EirGrid plc Full time

    About Us:EirGrid plc is the people behind Ireland's electricity grid. We operate the power system with world-leading levels of variable asynchronous renewable generation, ensuring that everyone has power when they need it.We are now transforming the power system for future generations. Our critical purpose is to transform the power system to enable our...


  • Tullamore, Uíbh Fhailí, Ireland Zoetis Full time

    Key Responsibilities:The successful candidate will be a Regulatory Compliance Manager - Manufacturing with a strong understanding of GXP manufacturing processes and regulatory requirements. In this role, you will be responsible for ensuring compliance with all relevant regulations and guidelines.You will lead investigations and improvement initiatives,...


  • Tullamore, Uíbh Fhailí, Ireland TN Ireland Full time

    Job Description">">This is a key role in the Global Manufacturing Technology (GMT) group, responsible for new product introduction, technology transfers, process validation, and continued process technical support to unit operations.">">Key Responsibilities">">Support new product introduction, process technology transfer, process validation, and preparation...


  • Tullamore, Uíbh Fhailí, Ireland Teleflex Full time

    Required Skills and QualificationsTo succeed in this role, you will need:A degree in a relevant Science or Engineering discipline2-3 years of experience in the medical device industry within quality or regulatoryTechnical writing expertiseBasic knowledge and understanding of US and/or international medical device regulations, standards, and guidance...


  • Tullamore, Uíbh Fhailí, Ireland TN Ireland Full time

    Social network you want to login/join with:Process Scientist Global Manufacturing Technology, TullamoreClient:Location:Job Category:OtherEU work permit required:YesJob Reference:4da62607a324Job Views:2Posted:02.04.2025Expiry Date:17.05.2025Job Description:POSITION SUMMARYThe Global Manufacturing Technology (GMT) group is responsible for new product...


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    Role SummaryWe're recruiting a Process Support Specialist to support our operations team. As a key member of our team, you'll be responsible for maintaining and updating our document system, ensuring compliance with regulatory requirements, and supporting batch release through timely quality notification completion and interim/summary report generation.Main...


  • Tullamore, Uíbh Fhailí, Ireland Life Science Recruitment Full time

    Job OverviewThis is an excellent opportunity to join a leading pharmaceutical organization based in the industry. We are looking for a highly skilled and experienced process engineer to lead our engineering team.About the Role:The successful candidate will be responsible for managing multiple projects from scope development, design, build/install and qualify...


  • Tullamore, Uíbh Fhailí, Ireland TN Ireland Full time

    Job DescriptionThis position plays a pivotal role in ensuring the quality and safety of medical devices. The successful candidate will be responsible for leading quality improvement initiatives and implementing state-of-the-art quality practices at an AST processing facility.The ideal candidate will have a strong background in quality management, with...


  • Tullamore, Uíbh Fhailí, Ireland Zoetis Full time

    About the Role:We are seeking a highly skilled Bioprocess Investigation Lead to join our manufacturing department. In this role, you will be responsible for leading investigations and improving processes to ensure compliance with regulatory requirements.Your expertise in bioprocess development and manufacturing will be essential in identifying and...