Regulatory Affairs Specialist
I'm currently working with a leading medical device company who have an opening for a Regulatory Affairs specialist to join them in there site in Galway. You will be joining a great team who specialise in manufacturing orthopaedic implants.
What will I being doing as a Regulatory Affairs Specialist?
- Manages FDA regulatory submission process, including authoring submissions as applicable for changes/Transfers.
- Oversees the development of dossiers for registration of products in countries outside the U.S, including authoring submissions.
- Provides ongoing input to value improvement engineering teams on possible regulatory impact of proposed changes.
- Applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organisation.
- Co-ordinate Change Notification for EU Design Dossier related to changes/Transfers.
- Establish and maintain regulatory information systems both electronically and hard copy.
Expected Areas of Competence
- Preparation of dossiers for product registrations outside the U.S.
- Preparation of submissions to the U.S. FDA
- Sufficient technical expertise to understand regulatory impact re. safety and efficacy of proposed manufacturing changes
- Monitoring of regulatory changes for impact to site quality system
- Participate in site internal compliance program
- Preparation for external audits
- Demonstrated strong writing and communication skills.
- Understands the overall business environment, the orthopaedic industry and the marketplace.
- Background in manufacturing with the ability to learn manufacturing processes.
- Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices.
- Ability to function well as a member of the team and build relationships between RA and other areas of the organisation.
- Able to identify and assess business risks for a given Regulatory strategy.
Education/ Experience Requirements
- Bachelor's Degree (4 year university degree) life sciences, technical (engineering), quality or related field.
- 2 year's experience in a regulatory position. Regulatory background should include the medical device area.
If you think the position in Galway is the step in the right direction for you and you have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Regulatory Affairs Specialist and are looking for more information, I will contact you upon application and discuss this further with you!
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