Regulatory Affairs Specilaist
I'm currently working with a leading medical device company based in Wexford.They are a medical device contract manufacturer. Due to growth, they need an ambitious Regulatory Affairs Specialist to join them.
This is a permanent role with great benefits.
What will I be doing as a regulatory Affairs Specialist?
- Ensure continuous compliance with
- FDA Quality System Regulation 21 CFR 820 (QSR)
- Medical Device Directive & Medical Device Regulation
- Health Canada Medical Device Regulations
- ISO13485 Medical Device Quality Management System
- Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
- All Internal Procedures· Assist with preparation and closing activities associated with:
- Assist with regulatory requests from customers and notified bodies, technical files etc.:
- United States FDA inspections
- ISO 13485 audits
- Other Regulatory Agency Audits
- Internal audits
- Process customer notification and regulatory requests
- Support Quality system and regulatory system improvements activities
- Be an active member of the team and work with all associates to develop a world class lean manufacturing system.
What I need to be a Regulatory Affairs Specialist ?
- Ability to communicate and work with people inside and outside the department.
- Ability to supervise
- Ability to co-ordinate, plan and organise Rigorous attention to detail.
- Excellent attention to detail and organisation skills.
- Ability to work to deadlines and on own initiative.
- Excellent interpersonal skills Excellent verbal and written communication skills.
- Working knowledge of Excel and Word.
If you'd like to discuss the chance of becoming Regulatory Affairs Specialist, please send across your current CV and we can have a confidential conversation about this opportunity.
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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales