Medical Device Regulatory Specialist

2 days ago

Cork, Cork, Ireland beBeeCompliance Full time €70,000 - €100,000

Job Title: Regulatory Compliance Expert

We are seeking a highly skilled and experienced Regulatory Compliance Expert to join our organisation. The successful candidate will report to the Senior Regulatory Manager and be responsible for ensuring compliance with regulatory standards, managing submissions, and maintaining relationships with notified bodies and FDA.

This role requires a strong working knowledge of medical device regulatory requirements and standard practices in the industry. The ideal candidate will be an enthusiastic self-starter with excellent organisational skills, able to balance immediate vs. long-term priorities and manage multiple tasks effectively.

Key Responsibilities:
  • Work closely with the QA Manager to ensure the effectiveness of the Quality Management System (QMS) in meeting regulatory requirements
  • Manage day-to-day regulatory activities, including product and compliance enhancements
  • Support notified body audits and other audits as required
  • Assist in the migration from MDD to MDR within the organisation
  • Collaborate with the wider team to ensure product manufacture and testing meets CE mark and FDA submission requirements
  • Work with suppliers to ensure process validations and risk management files meet regulatory standards
  • Provide strategic regulatory insight to team members regarding product development plans
  • Coordinate country-specific registration activities with the Commercial Team and Distributors
  • Maintain Post Market Surveillance activities, including logging customer complaints and adverse events, coordinating investigations, and addressing initiatives to improve products
  • Evaluate manufacturing and labelling changes, promotional materials, and assess their regulatory impact
  • Stay up-to-date with global regulatory trends and requirements, advising colleagues and external partners on compliance
  • Carry out other regulatory-related duties as required
Requirements:
  • Bachelor's degree in engineering or science with at least 4 years of experience in a medical device company
  • Regulatory certifications in MDR desirable
  • Minimum 4 years of experience in the medical device industry
  • Thorough understanding of ISO 13485 and ISO 14971, MDD & MDR
  • Proven track record in project management and ability to meet deadlines
  • Experience working directly with regulatory agencies
  • Strong problem-solving and communication skills
  • Self-motivated, highly organised, and detail-oriented
  • Excellent oral and written communication skills
  • Able to work as part of a cross-functional team

  • Medical Device Regulatory Specialist

    3 days ago

    Cork, Cork, Ireland beBeeRegulatory Full time €41,000 - €52,000

    Gain Experience in a Regulated Medical Device EnvironmentWe are seeking a highly motivated and detail-oriented individual to gain experience working in a regulated medical device company.The successful candidate will develop knowledge of quality, regulatory, and legal frameworks, requirements, legislation, processes, and procedures.Apply your skills to EU...

  • Packaging Specialist for Medical Devices

    11 hours ago

    Cork, Cork, Ireland beBeePackaging Full time €70,000 - €95,000

    Medical Device Packaging Specialist RoleCareerWise Recruitment is seeking a Medical Device Packaging Specialist to join a leading multinational based in Cork. This contract role has a minimum duration of 18 months.The successful candidate will be part of the Packaging project teams (R&D), responsible for designing and developing packaging components,...

  • Medical Device Packaging Specialist

    2 days ago

    Cork, Cork, Ireland beBeePackaging Full time €68,345 - €96,155

    Job Opportunity: Medical Device Packaging Specialist">Employment Overview:We are seeking an experienced and skilled professional to join our team as a Medical Device Packaging Specialist. This is a unique opportunity for a motivated individual to contribute their expertise in packaging design, development, and implementation.">Key Responsibilities:">">Design...

  • Senior Quality Assurance Specialist

    6 days ago

    Cork, Cork, Ireland beBeeQuality Full time €50,000 - €60,000

    Job Title: Quality Assurance SpecialistA leading medical device company is seeking a seasoned quality assurance specialist to join their growing team.The ideal candidate will possess strong technical expertise and excellent communication skills to effectively manage the quality management system (QMS).Key responsibilities include:Developing and implementing...

  • Medical Device Quality Assurance Specialist

    1 day ago

    Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000

    Unlock a Career in Medical Device Quality AssuranceAbout the RoleThe ideal candidate will be a key contributor to ensuring quality and compliance of innovative medical devices and life sciences products. The role focuses on implementing robust Quality Control processes, ensuring adherence to ISO standards, particularly ISO 13485. This will support the...

  • Senior Medical Device Packaging Specialist

    1 day ago

    Cork, Cork, Ireland beBeePackaging Full time €60,000 - €120,000

    Medical Device Packaging EngineerWe are seeking a skilled Medical Device Packaging Engineer to join our team. This is a contract role with a minimum duration of 18 months.Job Description:The successful candidate will be responsible for designing and developing best-in-class packaging solutions from early concept through commercialization for sterile and...

  • Medical Device Specialist

    9 hours ago

    Cork, Cork, Ireland beBeeMechanical Full time €60,000 - €80,000

    Job Role:Mechanical Engineer – Medical DevicesWe're seeking experienced contractors to support a critical medical device project for a leading manufacturer.About the JobExpertise in printed circuit board assembly (PCBA) coding and inspection systems is essentialA strong understanding of waterproofing and coating processes is requiredYou'll work on-site in...

  • Medical Device Process Development Specialist

    2 days ago

    Cork, Cork, Ireland beBeeInnovation Full time €60,000 - €90,000

    Process Engineer RoleWe are seeking an experienced professional to lead our process development initiatives. This key position involves active participation in multiple projects focused on the development, automation, and testing of medical devices.Key Responsibilities:Design and develop robust, high-yield manufacturing processes that ensure consistent...

  • Senior Medical Device Inspector

    3 days ago

    Cork, Cork, Ireland beBeeLaboratory Full time €60,000 - €80,000

    Job DescriptionWe are seeking a highly skilled Laboratory Technician to join our team in ensuring the quality of medical devices and processes.Key Responsibilities:Ensure Regulatory compliance with cGMPs for all medical device regulatory agencies.Represent QA as the primary point of contact for daily line support issues.Troubleshoot product and process...

  • Medical Device Development Specialist

    15 hours ago

    Cork, Cork, Ireland beBeeMedical Full time €75,000 - €85,000

    Job OpportunityA leading provider of laboratory services is seeking a proactive professional to support the growth of its medical device testing, consultancy, and packaging services across Ireland.This role is ideal for someone passionate about building client relationships and driving strategic business development in the life sciences sector.Key...