Medical Device Regulatory Specialist

5 days ago

Limerick, Limerick, Ireland beBeeCompliance Full time €45,000 - €65,000
Regulatory Compliance Expert

We are seeking a highly skilled Regulatory Compliance Expert to join our team. As a key member of our organization, you will serve as a liaison between our manufacturer and local affiliates or regulatory authorities.

Your primary responsibility will be to assess complaints from global customer support and delivery centres to determine if events meet regulatory reporting requirements. You will utilize complaint software systems for processing complaints and generate appropriate regulatory reports based on assessment.

You will liaise effectively with regulators on all issues related to regulatory reporting and ensure that confirmed reportable events are escalated to the appropriate personnel in a timely manner.

Additional responsibilities include communicating with other companies globally as necessary for reporting, generating responses to inquiries on AE reports from various global regulatory authorities, and maintaining an excellent understanding of global medical device regulations.

Furthermore, you will be responsible for implementing applicable regulatory requirements in accordance with ISO 13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSR 21 CFR Part 820.

Key Responsibilities:
  • Assessing complaints from global customer support and delivery centres
  • Liaising with regulators on regulatory reporting
  • Generating regulatory reports based on assessment
  • Maintaining knowledge of global medical device regulations
  • Implementing regulatory requirements in accordance with relevant standards
Required Skills and Qualifications:
  • Third-level qualification in Science/Engineering desirable
  • A number of years experience in a regulated industry in a similar role required
  • Thorough knowledge of EU & US medical device regulatory requirements
  • Knowledge of regulatory requirements in MDSAP countries
  • Good communication and inter-personal skills
  • Proven problem-solving skills
  • Good computer skills including knowledge of Microsoft Office
  • Proven organisational skills
  • High self-motivation
  • Willingness and availability to travel on company business

  • Medical Device Regulatory Liaison

    2 days ago

    Limerick, Limerick, Ireland beBeeRegulatory Full time €55,000 - €70,000

    Regulatory Communications Specialist Overview The Regulatory Communications Specialist plays a key role as a communication liaison between manufacturers and regulatory authorities. This position is responsible for assessing complaints to determine if they meet reporting requirements, generating regulatory reports, and liaising with regulators. Key...

  • Regulatory Communications Specialist

    2 weeks ago

    Limerick, Limerick, Ireland Cook Medical Full time

    Overview The Regulatory Communications Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and...

  • Regulatory Communications Specialist

    4 days ago

    Limerick, Limerick, Ireland Cook Medical Full time

    Overview The Regulatory Communications Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and...

  • Medical Device Security Specialist

    2 weeks ago

    Limerick, Limerick, Ireland beBeeSecurity Full time €60,000 - €90,000

    Job OverviewWe are seeking a Product Security Specialist to join our team. The successful candidate will be responsible for conducting product security risk assessments, preparing reports, and presenting findings to clients and internal teams.The role blends technical expertise and business engagement, requiring the ability to partner with cross-functional...

  • Medical Devices Innovator

    3 days ago

    Limerick, Limerick, Ireland beBeeInnovator Full time €90,000 - €105,000

    Medical Devices Innovator OpportunityWe are seeking a highly skilled and innovative Medical Devices Innovator to lead the development of cutting-edge medical devices. As a key member of our team, you will be responsible for designing and developing prototypes that meet clinical and design requirements.Main Responsibilities:Develop innovative medical device...

  • Medical Device Innovation Specialist

    2 weeks ago

    Limerick, Limerick, Ireland beBeeInnovation Full time €69,300 - €217,500

    Transforming Ideas into Reality: A Role for Medical Device InnovationIn this dynamic and challenging position, you will play a pivotal role in driving innovation and product development within the medical device industry.You will be responsible for leading end-to-end design and development of advanced medical devices that positively impact patients' lives...

  • Medical Device Innovator

    1 week ago

    Limerick, Limerick, Ireland beBeeRdEngineer Full time €60,000 - €120,000

    Job OpportunityWe are seeking an experienced R&D Engineer to join our dynamic endoscopy team in Limerick. This 12-month contract role offers a fantastic opportunity to build your career in the medical device industry.In this position, you will work closely with the development team to design products that positively impact patients' lives globally. Your...

  • Senior Usability Specialist

    2 weeks ago

    Limerick, Limerick, Ireland beBeeHumanfactors Full time €60,000 - €80,000

    Job DescriptionOur client in Limerick is seeking a seasoned Human Factors Engineer to join their European hub for R&D and innovation.As they develop Class I to Class III medical devices, you will work across disciplines to support bringing ideas from concept to market under high standards of quality, regulatory compliance and patient safety.You will be...

  • Advanced Medical Device Designer

    1 week ago

    Limerick, Limerick, Ireland beBeeDevelopment Full time €36,000 - €55,000

    Research and Development Engineer RoleWe are seeking an experienced Research and Development Engineer to join our dynamic endoscopy team in Limerick. The ideal candidate will have a strong background in designing Class II/III devices, with experience in endoscopy being a plus.This is a 12-month contract role that offers the opportunity to design products...

  • Senior Medical Device Innovator

    5 days ago

    Limerick, Limerick, Ireland beBeeInnovation Full time €140,000 - €190,000

    Job Title: Senior Medical Device InnovatorAbout the Role:We are seeking an experienced and ambitious individual to join our team as a Senior Medical Device Innovator.This is a rare opportunity to make a real impact in the medical device space, working on cutting-edge projects that can change lives.Key Responsibilities:Medical Device Design: Develop...