Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve
Produce and review the technical and regulatory documentation in accordance with ISO 13485
and regulatory requirements in line with continuous improvement programmes and/or changes
required through standards.
Investigate, remediate and successfully conclude all regulatory issues that are product related.
Manage process for formal discontinuation of product
Maintain a keen awareness of customer requirements, applications and manner of use (e.g.
attendance at in-house training sessions).
Participate actively in company/ divisional/ functional meetings.
Support and, when requested, lead the regulatory team in processing global product registrations
and approvals for chosen markets
Support Risk Management activities
Understand and apply quality assurance procedures in line with ISO 13485:2016 quality
management system standards, the Medical Devices Directive 93/42/EEC (as amended) and
Medical Device Regulation MDR 2017/745.
Ensure the company has up-to-date intelligence relating to upcoming changes that impact
Ensure personal compliance with internal regulatory, quality and other procedures.
Ensure the company is compliant to global regulatory requirements for quality systems and
product registrations / approvals including MDSAP & FDA
Conduct training, where necessary of company personnel who interact with the Regulatory
Department regarding new regulations and policies that could impact the company’s products or
Other duties as necessary to support the operations of the Quality and Regulatory Department.
Conduct Regulatory Review as independent function across to the divisions of Kimal PLC
Bachelor degree in Engineering or Science related field
Minimum 5 year’s experience in Regulatory Affairs within the Medical Device industry (MDD)
Broad knowledge of post market activities
Broad knowledge of quality systems and procedures
Broad knowledge of global medical device regulations and international standards
PHARMA Responsible Person (not essential)