Senior Regulatory Affairs Specialist

45000.00 - 50000.00 GBP Annual + GBP45000 - GBP50000/annum
03 Oct 2017
31 Oct 2017
Contract Type
My client is an innovative and trusted manufacturer and supplier of Medical Device Products to hospitals across the world.
Products include invasive surgical tools and procedure packs and over 1 million items are manufactured each year in the UK.
This role is accountable for ensuring the company and products meet the standards required for continued regulatory compliance. It is also accountable for ensuring post market activities are carried out in line with relevant regulatory requirements. You will ensure the appropriate licensing and legal compliance of the company's medical products and other activities.
Below is a taster of some of the main activities this role will perform, a full and detailed job description can be provided upon request:
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).
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 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.
This is a fantastic opportunity to join a well-established business and really make an impact on Quality and Regulations. Reporting to the Group Quality and Regulatory Manager you will play a vital role in ensuring the continued success of the Quality Department within the business.
Commutable from: Redditch Kidderminster Birmingham Worcester West Bromwich Alcester Solihull Coventry Stourbridge Bromsgrove West Midlands
Key Words: Quality Assurance Manager QMS Medical Device Healthcare ISO13485

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