- Hiring hub
- Our services
- Our locations
- Our sectors
- Client testimonials
- Submit vacancy
- IR35 hub
- Submit vacancy
- Career advice
- CV information
- Employment advice
- Interview advice
- Career advice from our recruitment specialists
- About us
Regulatory Affairs Specialist
Our client are a leading medical device company who are looking for a Regulatory Affairs Specialist.
If you are a Regulatory professional with a proven track record within the Medical Device or Pharmaceutical arena we want to hear from you!
This is a fantastic opportunity to be a part of a growing and innovative company developing medical devices.
As a Regulatory Affairs Specialist you 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
What we are looking for…
- Degree educated, preferably in Life Sciences, Pharmacy, Engineering or another relevant scientific discipline
- Proven Regulatory experience in Medical Devices/Pharmaceuticals
- Hands on experience of creating and maintaining technical documentation in accordance with MDD/MDR
- Experience with assessing data against regulatory requirements for Safety and Performance
- Ability to demonstrate knowledge of European Medical Device regulations (MDD and MDR) in Class I , Class I Sterile and Class IIa devices at a minimum
- Experience of working with ISO 13485 and ISO 14971
- Experience of dealing directly with Notified Bodies and Competent Authorities eg MHRA
Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.
Gattaca Plc provides support services to Matchtech and may assist with processing your application.
You can not apply for this job as its status is Closed.