Current jobs related to Device Development Assurance Expert - Dublin, Dublin City - beBeeDevelopment

  • Device Development Assurance Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeDeviceDevelopment Full time €60,000 - €85,000

    We are seeking a seasoned Device Development Assurance Specialist to join our global team. In this role, you will play a critical part in the design, development and commercialization of device technology solutions.This position involves supporting and guiding device development programs through the design and development lifecycle for combination products....

  • Device Development Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €100,000 - €150,000

    Job OverviewThe Principal Device Development Assurance Scientist/Engineer plays a critical role in ensuring the design and development of combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices comply with regulatory requirements outlined in quality management systems.This involves establishing and maintaining...

  • Device Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeDevice Full time €70,000 - €90,000

    Job Title: Device Assurance SpecialistEnsure Medical Device Compliance and Development ExcellenceJob Description:This role is focused on guaranteeing adherence to design control requirements during medical device development. You will collaborate closely with cross-functional teams to develop innovative device technologies for drug delivery.Provide guidance...

  • Principal Device Development Assurance Scientist/Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland Viatris Full time

    Principal Device Development Assurance Scientist/Engineer (18 months Fixed Term Contract)Join to apply for the Principal Device Development Assurance Scientist/Engineer (18 months Fixed Term Contract) role at ViatrisPrincipal Device Development Assurance Scientist/Engineer (18 months Fixed Term Contract)1 week ago Be among the first 25 applicantsJoin to...

  • Senior Quality Assurance Expert

    1 week ago

    Dublin, Dublin City, Ireland beBeeQualityAssurance Full time €60,000 - €80,000

    Job Title:Senior Quality Assurance ExpertJob DescriptionWe are seeking a Senior Quality Assurance Expert to lead our day-to-day quality management system (QMS) implementation and maintenance. This role will be responsible for providing quality support across manufacturing, supply chain, and design assurance functions.Responsibilities- Lead the implementation...

  • Orthopaedic Device Expert

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeOrthopaedic Full time €45,000 - €50,000

    Job Title: Orthopaedic Clinical Support SpecialistRole Overview:We are seeking a highly motivated and skilled professional to join our team as an Orthopaedic Clinical Support Specialist. This role involves providing technical advice and training to customers on the safe and effective use of surgical devices and techniques.Key Responsibilities:Provide expert...

  • Device Development Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeDevice Full time €90,000 - €110,000

    Job DescriptionThe role of Principal Device Development Assurance Scientist/Engineer involves supporting and guiding device development programs throughout the design and development lifecycle for combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices.This includes establishing, maintaining, and providing...

  • Device Development Regulatory Strategist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €93,359 - €124,941

    Lead Regulatory Expert for Device DevelopmentThis is a senior role that requires expertise in regulatory compliance, strategy development, and team leadership. As a Lead Regulatory Expert, you will be responsible for ensuring that device development projects comply with relevant regulations, standards, and guidelines.Key Responsibilities:Develop and maintain...

  • Medical Device Quality Assurance Role

    1 week ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €80,000 - €100,000

    Quality Assurance SpecialistThis role involves driving the day-to-day implementation of the quality management system, with a focus on continuous improvement. The successful candidate will work closely with manufacturing, supply chain, and design assurance teams to ensure that all necessary QA activities are planned, executed, and...

  • Medical Device Development Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeProgram Full time €90,000 - €105,000

    Program Management RoleAs a seasoned Program Manager, you will be responsible for overseeing the success of strategic projects and initiatives within the medical device industry. You will lead cross-functional teams, ensuring alignment with business goals, and deliver innovative medical devices that enhance patient care.Lead Multiple Programs: Manage...

Device Development Assurance Expert

3 weeks ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €90,000 - €120,000

Role Summary:

We are seeking an experienced Device Development Assurance Scientist/Engineer to join our Global Device Development organisation. This is a unique opportunity to make a significant impact in the development of innovative device technology solutions for our generic and branded products.

The successful candidate will be responsible for supporting and guiding device development programs through the design and development lifecycle, ensuring compliance with design control requirements and relevant regulations.

This role requires strong analytical and problem-solving skills, as well as excellent communication and collaboration abilities. The ideal candidate will have experience in device design controls, ISO/FDA requirements, and GMP environments.

Key Responsibilities:

  • Support and provide guidance for device development programs through the design and development lifecycle.

  • Ensure compliance with design control requirements and relevant regulations.

  • Establish and maintain Design History Files for development programs.

  • Collaborate with affiliate sites, collaborators, and third parties to ensure appropriate objective evidence and controls.

  • Support integration and assess compliance with design control requirements of acquired combination products and medical devices.

  • Participate in third-party audits.

  • Maintain awareness of industry best practices and implement improvement actions.

Requirements:

  • Education: Degree or Masters in engineering or science/life science.

  • Industry: Medical Device or Pharmaceutical (with devices).

  • Proven experience in similar level/general experience in industry.

  • Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment.

  • Experience in implementation of device design controls and ISO/FDA requirements.

  • Demonstrated understanding of GMP, Quality Management System, and relevant Regulations.

  • Strong problem-solving and analytical skills.

  • Possess knowledge of core manufacturing/lab operation principles.

  • Excellent communicator with ability to work flexibly across a multi-disciplinary team.

Benefits:

  • Competitive salary.

  • Bonus scheme.

  • Health insurance.

  • Pension.

About Us:

We are a global company dedicated to building a diverse, inclusive, and authentic workplace where everyone can thrive.

Our mission is to redefine healthcare not as it is, but as it should be.

We offer a collaborative culture that fosters courage and resilience, empowering employees to realize their full potential.

We operate from multiple sites worldwide, including Dublin, Ireland, Cambridge & Sandwich, UK, and Southpointe, Pittsburgh, USA.

We develop device technologies to enable delivery for our large and growing generic and branded products around the globe.

We support innovative technology solutions to provide healthcare solutions for our patients.

We are committed to creating better health for a better world, one person at a time.