Senior Regulatory Affairs Specialist

Careerwise Recruitment

Sligo

A Senior Regulatory Affairs Specialist is required by Careerwise Recruitment to work for our Sligo based medical device manufacturing client. THE ROLE: * Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned. * Ensures a thorough understanding of the products they are assigned. * Communicates country/region specific regulatory requirements. * Develop global regulatory strategies for medical devices in collaboration with R& D and clinical functions. * Advise other functional units (R&D, engineering, marketing, quality etc) of the requirements in each target market. * Ensure the outputs from the individual functional units meet the applicable regulatory requirements. REQUIREMENTS: * Third Level Qualification preferably in Science/Engineering; 3 years experience in a regulated industry in a similar role desirable. * Has knowledge of regulatory requirements in accordance with ISO13485, MDD93/42/EEC and FDA QSR 21CFR Part 820 as required. * Knowledge of medical device quality standards and guidance documents. Please call Michael O'Connor today for further information on 091-452410 or email moconnor@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

1802 days ago