Regulatory Affairs Specialist

Sigmar Recruitment

Tipperary

My client a Tipperary has a vacancy for a Regulatory Affairs Specialist. He/she will beresponsible for activities which lead to, & maintain reg approval to market devices. Additionally, this person is responsible for assessment of changes for regulatory implications. Key duties will include (but not limited to) : Responsible for submission of global regulatory applications & internal regulatory file documentation. Reviews & signs-off on product & manufacturing changes for compliance with applicable regulations. Authoring, reviewing and submitting documents. Duties done in accordance to regulatory requirements and project timelines. Respond to health authority questions or local subsidiary requests for additional information. The ability to develop & implement regulatory strategies for new & modified products. Works with moderate work direction and is skilled and knowledgeable to the position. What you'll need ! Bachelor's Degree (level 8) or higher inlife sciences, engineering or related field. Circa 3 years+ regulatory affairs experience in a regulated industry. Working knowledge of FDA & international regulations & product developement processes. Experience working directly with FDA, notified bodies and/or health authorities is desired. For more information please call Colin on 021-4847131 or E-Mail codonnell@sigmar.ie. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.

2044 days ago