Head Of Vascular Access Regulatory Affairs

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 programs 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.