Senior Regulatory Affairs Specialist
Kimal® are an innovative and trusted developer, manufacturer and supplier of customised procedure packs and vascular access devices for use across a range of clinical departments. As a proudly independent company, our responsiveness and agility, combined with strong partnership and collaboration ethos, make us a supplier of choice to health organisations the world over.
We are currently looking for a Senior Regulatory Affairs Specialist to support and ensure the company and products meets the standards required for continued regulatory compliance.
You will be accountable for ensuring post market activities are carried out in line with relevant regulatory requirements and that appropriate licensing and legal compliance of the company's medical products and other activities are present.
Main Duties and Responsibilities:
- 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
- Support 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 CMDCAS
- 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.
The successful candidate will have a Batchelor degree in Engineering or Science related fields and have worked previously in a Regulatory Affairs role within the Medical Device Industry (MDD).
Required Qualifications and Experience:
- Minimum 5 years? 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
How to apply
If you feel you have the relevant skills and experience for this position, please click on ?Apply? and upload your CV. You will then be sent an email with a link to complete an online application form. You must complete both parts of the application process to be considered.
This job was originally posted as www.jobsite.co.uk/job/959245087