A Senior Technical Writer is required by Careerwise Recruitment to work for our Galway based medical device manufacturing multinational client.
Role of this position
- 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.
- 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 firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)