Current jobs related to Medical Device Compliance Specialist - Dublin, Dublin City - beBeeExpert
-
Dublin, Dublin City, Ireland beBeeRegulatory Full time €60,000 - €80,000Regulatory Affairs Expert OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to play an active role in developing the regulatory strategy for medical device companies.The ideal candidate will have extensive knowledge of quality management systems, design controls per ISO 13485, and current International and European...
-
Dublin, Dublin City, Ireland beBeeMedical Full time €120,000 - €150,000Regulatory Specialist for Medical DevicesThis position requires a subject matter expert in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance.The successful candidate will maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest...
-
Medical Device Regulatory Compliance Expert
1 week ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €50,000 - €65,000**Job Overview**We are seeking an experienced Regulatory Affairs Specialist to join our team. This role will play a key part in the development of our regulatory strategy and ensure compliance with relevant regulations.**Key Responsibilities**Support the creation and maintenance of product design and technical documentation in compliance with relevant...
-
Chief Medical Device Technical Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeTechnical Full time €80,000 - €100,000Job OverviewWe are seeking a skilled medical device technical specialist to lead the implementation of a Quality Management System (QMS) aligned to ISO 13485.The ideal candidate will have experience in medical device roles and a proven track record of designing and implementing quality management systems.A strong understanding of ISO 13485 and related...
-
Medical Device Development Lead
2 weeks ago
Dublin, Dublin City, Ireland beBeeDevelopment Full time €85,962 - €124,949Lead Medical Device Development SpecialistWe are seeking an experienced medical device development expert to oversee the design, testing and evaluation of drug-device combination products.Develop subject matter expertise for Combination Product developmentPlan and execute design verification and reliability strategiesDesign test methods and specifications to...
-
Senior Medical Device Development Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeMedical Full time €90,000 - €122,000Job Title: Senior Medical Device Development SpecialistThis role is for a highly skilled specialist to join our team on a permanent basis.The position involves leading the design, development and performance evaluation of drug-device combination products ensuring they meet regulatory standards.Provide technical expertise to support the development of...
-
Medical Device Development Specialist
1 week ago
Dublin, Dublin City, Ireland beBeeLab Full time €45,000 - €60,000Job OverviewWe are seeking a highly skilled and detail-oriented R&D Lab Specialist to join our team. As a key member of our R&D lab, you will play a crucial role in supporting the development of cutting-edge medical devices.
-
Medical Devices Regulatory Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €35,000 - €45,000Regulatory Support RoleWe are seeking a highly organized and detail-oriented professional to provide administrative and regulatory support within our Medical Devices department.Key Responsibilities:Process regulatory cases, correspondence, and certificates of free saleManage data entry, updates, and document control for compliance with EU and national...
-
Senior Medical Device Development Specialist
1 week ago
Dublin, Dublin City, Ireland beBeeDevelopment Full time €100,000 - €140,000Senior Medical Device Development SpecialistWe are seeking a highly skilled professional to lead the design, development, and performance evaluation of drug-device combination products in our team in Dublin.About the Role:The successful candidate will provide subject matter expertise to support formulation and manufacturing development activities for...
-
Medical Device Development Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeProgram Full time €90,000 - €105,000Program 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...
Medical Device Compliance Specialist
2 weeks ago
Job Title: Clinical Regulatory Specialist
The role of a Clinical Regulatory Specialist is pivotal in the development of innovative medical devices. Key responsibilities include supporting design development, verification, clinical trials, validation, and regulatory approval.
Key Responsibilities- Coordinate global clinical trial execution, including site activation, enrolment, follow up and closure, according to study schedules.
- Communicate study status and timelines, escalating unresolved issues to line managers as needed.
- Develop study documents, such as study protocols and Investigator's Brochure, and regulatory submission deliverables.
- Maintain the clinical study electronic database and ensure accurate information is readily available.
- Support trial/regional enrolment strategy and execution, overseeing clinical product inventory and timely supply of materials to clinical sites.
- Manage essential documents and Trial Master File, ensuring inspection-readiness, and identify opportunities for continuous improvement.
- Ensure compliance with internal and external regulatory requirements.
- Review and assess changes affecting clinical investigations, collaborating with cross-functional teams.
- Prepare regulatory submissions for clinical and commercial applications, as applicable.
- Interpret new or revised medical device regulations and standards, developing internal procedures for continuous compliance.
- Degree or master's degree in science or engineering, or related disciplines.
- Experience in medical device Clinical Affairs or Regulatory Affairs preferred.
- Working knowledge of FDA, GMP, QSR and ISO 13485 requirements preferred.
- Excellent communication, organisational and time management skills.
Availability to travel is required.
