Regulatory Affairs Specialist
I am working with one of the world's leading medical technology companies, they are currently seeking a regulatory affairs specialist for an 8 week contract.
Role: Regulatory Affairs Specialist
Contract: 8 week contract
- Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
- Supports the product lifecycle through to obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
- Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
- Viewed as regulatory team resource.
- Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
- Assisting in SOP development and review
- Ability to comply with constantly changing regulatory procedures and prioritize work effectively
- Ability to communicate and network with regulatory personnel to obtain relevant information
- B.Sc in Engineering, Sciences or equivalent preferred
- 1-3 years regulatory experience in the medical device or pharmaceutical industry
- RAC certification (preferred)
- Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance
This is an excellent opportunity for an experienced Regulatory Affairs Specialist who is looking for a role in Cork.
For immediate consideration please apply with an up to date CV. Not sure yet? No CV ready? Give me a call for more information
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