Senior Regulatory Affairs Specialist
- Sligo, Republic of Ireland
- Medical Devices, Quality Assurance (QA), Operations, Regulatory Affairs (RA)
The team is led by a renowned QA / RA manager, who has worked on growing the team with talented specialists for the last 12 months. You will be working alongside a structured team, alongside Specialists who have a broad wealth of experience within the industry.
Role: Regulatory Affairs Specialist
Contract: An initial 6 month hourly rate contract
Your role as a Regulatory Affairs Specialist will be to aid in the development of regulatory strategies and perform activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in target markets. You will also be given the responsibility of communicating directly with notified bodies and regulatory authorities.
Company / Culture:
The client is one of the leading providers and manufacturers of health care solutions. They have a continuous rising portfolio of effective health care solutions and they make a significant influence towards protecting and improving people's health. They do offer levels of remote work, and provide flexi time hours. The company are a family owned company, ensuring that they have an excellent culture on site.
Your Regulatory Background:
5+ years experience as a Regulatory Affairs Specialist within a medical device / pharmaceutical company. Must have experience with Regulatory Submissions, and experience in working in accordance with ISO13485:2016 standards. It is also desirable to have a proven experience working within a team environment.
What will you be doing?
The company are currently under expansion, and they require an experienced Regulatory Affairs Specialist to join their team to work on an exciting new phase of their project. You will be co coordinating multiple projects and providing regular reports to regulatory management and others as required. You will also be responsible for providing support to current products as needed including providing information on change requests etc.
No CV ready? Not sure yet? Feel free to contact me for further details
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales