Regulatory Affairs Specialist
My Client, a renowned company within the Medical Industry are looking for a Regulatory Affairs Specialist to join their Crawley based team.
SUMMARY OF THE ROLE
The role will be responsible for supporting Regulatory Compliance of medical devices and processes throughout the product lifecycle from initial research to product release and post market surveillance; ensuring adherence to ISO13485:2016, Medical Device Directives (MDD) and Medical Device Regulations (MDR) and other ISO standards as required. This is a key role working closely with the Quality Assurance and Regulatory Affairs Manager and the Regulatory Team.
MAIN DUTIES AND RESPONSIBILITIES
* To support the day to day management and co-ordination of the technical documentation, including
Clinical Evaluation Reports, Technical Files and Risk Management as per the requirements of ISO13485:2016 and applicable medical device regulations
* To assist with Post-Market Surveillance, writing plans and reports and reviewing data from customers
* To monitor changes in global medical device regulatory requirements
* Provide regulatory guidance to other departments e.g. Sales and Marketing when needed including assistance with regulatory submissions
* To help conduct material safety and biological assessments in accordance with ISO10993
* To support Research and Development teams by providing regulatory guidance to ensure compliance through all stages of new product development and entry into new markets
* To assist in maintaining a proactive compliance culture throughout the organisation and assist quality activities to achieve company KPIs
* To participate in continuous improvement, corrective actions and business risk minimisation
* To support audits by external regulatory bodies
* To represent the Quality Assurance and Regulatory Affairs Department at internal meetings and Training events
* To undertake any internal/external training as required
* To perform other duties as requested by Senior Management
* Responsibility to adhere to the Company's Health and Safety policy at all times and operate and promote the development of quality standards and procedures taking ownership of tasks and to seek new improved ways of doing things
Shifts: Monday - Thursday 9am-5pm. Friday finish at 1pm
As a Regulatory Affairs Specialist working with this company, you will be rewarded with a competitive basic salary You will also be entitled to an excellent range of benefits.
If you are interested in this role, please click 'APPLY' and submit your CV for immediate consideration.
All successful candidates will be contacted within two working days of application.