Job Information

Job Opening Status






Work Experience

5 years

Job Description

 Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve compliance
 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 compliance.
 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 processes.
 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 EXPERIENCE REQUIRED
 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)

Apply for this Job

Please login or register to apply