Senior Regulatory Affairs Specialist
- Sligo, Republic of Ireland
- Medical Devices, Engineering, Quality Assurance (QA), Operations, Regulatory Affairs (RA)
One of my key clients in Sligo, are currently seeking an experienced Regulatory Affairs Specialist to join their team, on an initial 6 month hourly rate contract. The company are a global medical device company, specialising in the manufacture of wound care products and therapies. They are a family owned company, ensuring that they have an excellent culture on site.
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 on site. You will also be involved in performing activities involved with obtaining and maintaining regulatory approval to commercialise medical devices for the company.
- Maintain an excellent understanding of global medical device regulations, as assigned including regulatory requirements in accordance with ISO13485:2016 standards.
- Ensure a thorough understanding of the ongoing projects on site.
- Ensure the outputs from individual functional units meet regulatory requirements.
- Plan and prepare regulatory submissions for target markets for new products, product changes and re-registrations as required.
- Communicate directly with notified bodies and other regulatory authorities to ensure product approvals are gained in a timely manner.
- Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
- Degree in Science / Engineering
- Have a broad knowledge of regulatory requirements in accordance with ISO13485 and FDA standards as required.
- Knowledge of medical device quality standards / practices or similar regulated environments / industries.
- Good communication and interpersonal skills.
- Proven organisational skills.
- 4+ years experience within the medical device industry.
No CV ready? Not sure yet? Feel free to contact me for further details.
This is an excellent opportunity to work within a global medical device company, alongside talented regulatory specialists.
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