Senior Regulatory Affairs Specialist

Sigmar Recruitment

Galway

Our client based in Galway city is now seeking a Senior Regulatory Affairs Specialist . The Senior Regulatory Affairs Specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining of all quality systems and related documentation. Key role of this position is to support company goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company’s range of medical devices. Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS and other International Regulations. MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Graduate with Engineering or science degree or equivalent experience. Qualified systems lead auditor for ISO 13485 and MDD compliance. Minimum of 3 years experience in a Medical device regulatory affairs role. Competent in preparing written communication and correspondence. Ability to make verbal presentations and effectively negotiate with regulatory, technical, medical and legal professionals. Comprehension of engineering principles adequate to allow participation in New Products Development and field complaint issues. 3 -5 years experience in a regulatory affairs role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment. To apply email your CV to rbrennan@sigmar.ie or call Rachael on 091 455306 for more information. All applications are dealt with in the strictest of confidence. This job originally appeared on RecruitIreland.com.

2796 days ago