I am currently working with a leading medical device company located in Offaly, Who currently have an immediate opening for a Senior Regulatory Affairs Specialist.
You will be joining a great team who help millions of patients each year.The company is known for its great culture and management open door policy.
What you will be doing as a Senior Regulatory Affairs Specialist?
- Determines regulatory pathways for various projects including product classification and subsequent regulatory submission to Regulatory agency/Distributor as required.
- Construction of Technical Files and associated documentation and/ or regulatory rationales.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Interacts with various levels of management, external agencies and companies.
- Analyzes and makes recommendations regarding field complaints.
- Remains current on developing regulations and revision of systems for continued compliance.
- Participates in and assists with facility inspections, Notified Body Audits, TGA and other inspections/ audits as required.
- Assists with supervision of department staff, as required.
- Performs other related duties and tasks, as required.
What you need to be a Senior Regulatory Affairs Specialist?
- Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines
- 4-6 years of related industry experience.
- Demonstrated knowledge of the Medical Devices Directive (Preferable) (93/42/EEC, as amended), U.S. FDA regulations and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other.
Don't miss out on a great opportunity to join an exciting company,If you are interested please apply with an up to date CV.
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