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Regulatory Affairs Manager (EMEA)

Reference:JCANKM-765546 Location: Roscommon
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

ARegulatory Affairs Manager (EMEA)is required to join a leadingMedical Device organisationinAthlone.

Your role:
As the Regulatory Affairs Manager you will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for company products globally.

Your responsibilities:

  • Primary responsibility for regulatory affairs in the EMEA region.
  • Pursue relevant information pertaining to new developments in regulatory affairs by maintaining contact with other professionals in the field
  • Represent the company’s business interests on selected international working groups
  • Keep track of and provide input on updated and revised standards
  • Ensure the site regulatory procedures are aligned with corporate procedures
  • Ensure compliance to Athlone site Quality Management System
  • Meet with regulatory agencies and competent authorities as required
  • Regulatory lead for Authorized Representative
  • Regulatory lead for labelling activities associated with new product introductions for EMEA and updates as required for EMEA requirements
  • Responsibility for regulatory submissions and maintenance in EMEA
  • Communicate to management on regulatory activity in EMEA
  • Schedule, plan and manage regulatory activities in EMEA
  • Provide regulatory support to the EMEA organisation
  • Represent regulatory at International management review
  • Quality Engineering
  • Strategic projects -GLS, UDI, ECM
  • Dotted line Manager for BU RA Specialists
  • Audit support for design control elements of new product introduction and review of existing technical files
  • Maintenance of existing registrations, renewal as required

What you need:

  • Degree level life sciences, engineering or scientific qualification, Masters an advantage
  • 7 years minimum quality system or regulatory experience in the medical industry required.
  • Knowledge of International Quality and Regulatory requirements and regulations including but not limited to FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL requirements.
  • Design Control experience supporting new product introductions, design changes including Risk Management
  • Expert in assembly and submission of Design Dossiers and Technical Files
  • Direct interaction with Regulatory Authorities and Notified bodies at European Level.
  • Experience in preparation for notified body inspections
  • Experience in project management

What you have:

  • Approachable and enthusiastic. Flexible and adaptable.
  • Able to work on own initiative and as a team player.
  • Good organizational skills with cultural awareness and sensitivity.
  • Excellent interpersonal skills and ability to work with people from different cultural backgrounds to achieve results.
  • Ability to work in cross functional teams.
  • Influence others: ability to influence across functions and geographies.
  • Demonstrates leadership and management of teams.