Regulatory Affairs Specialist
- Reference: Regulatory Affairs Specialist
- Closing Date: 01/06/2020
- Type: General Application
Welland Medical, one of the leading ostomy brands in the UK and worldwide, specialise in the design, development and manufacture of innovative stoma care appliances and accessories. Celebrating over 30 years of business, Welland Medical is renowned for manufacturing ground breaking solutions that enhance the lives of ostomates throughout the world. Situated in a purpose-built state of the art research, development and manufacturing facility, Welland Medical employs a growing workforce of over 200 skilled employees. Part of the privately owned CliniMed Group, which established in 1982 now employs 800 in the UK and provides specialist products and services to the healthcare market.
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
A degree of flexibility is needed and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role. All duties must be carried out in compliance with company Quality System, health and safety policies and regulations set out in the Medical Device Directive.
Quality is an integral part of the company’s mission to deliver innovative products and service. All members of staff are responsible for operating and promoting the development of quality standards and procedures.
The company is committed to a culture of continuous improvement. All members of staff are expected to take ownership of tasks and seek new and improved ways of doing things.
FOR ALL APPLICATIONS AND TO REQUEST A FULL JOB DESCRIPTION PLEASE CONTACT firstname.lastname@example.org
A COVERING LETTER AND CV WILL BE REQUIRED WITH ALL APPLICATIONS
Closing date: 1st June 2020