Senior Technical Writer

CAREERWISE RECRUITMENT

GALWAY

A Senior Technical Writer is required by Careerwise Recruitment to work for our Galway based medical device manufacturing multinational client. THE ROLE: * Independently researches, prepares, writes, edits and reviews clinical evidence documents. * Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities. * Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions. * Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators. * Collaborates with cross-functional teams to ensure high quality and successful project delivery. REQUIREMENTS: * Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports. * Proficient in searching medical literature and databases for clinical and technical information. * Ability to read, analyse, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information and complex documents. * Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards. * Effective written and verbal communication skills in the area of technical/clinical applications. 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.

1689 days ago