We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.Job DetailsJob DescriptionThis position is responsible for the creation of scientific and regulatory documents while working with a cross-functional team in accordance with the highest quality standards. The Senior Medical Writer is responsible for performing, preparing, and maintaining Clinical Evaluation Reports and/or Performance Evaluation Reports for CE technical documentation in accordance with the requirements of the EU Medical Device Regulations (MDR) and/or EU In Vitro Diagnostics Regulations (IVDR) and/or Clinical Risk-Benifit Assessment Reports (CRBA) and related guidance documents (e.g. MEDDEV.2.7./1 Rev. 4). This involves analyzing available safety and performance data for medical devices/in vitro diagnostics and preparing clinical data documents that support regulatory submissions for the EU, US, and other international markets.The Senior Medical Writer also assists with writing and reviewing regulatory documents related to the preparation, conduct and reporting of clinical investigations and other PMCF/PMPF activities.Responsibilities
Creation and maintenance of regulatory documents related to clinical data of Haemonetics products (CEP/PEP; CER/PER; PMCF/PMPF;SRV; CPR; LSR; CRBA) in liaison with other departments
Plan and execute structured literature searches, identify and analyze relevant clinical data
Write Clinical Evaluation and Performance Evaluation plans and reports in compliance with applicable regulatory requirements (EU MDR, EU IVDR, MEDDEV 2.7/1, MDCG guidance documents)
Write protocols, safety plans and reports in liaison with Medical and Regulatory Affairs
Support Medical Affairs and Regulatory Affairs in development and execution of regulatory strategies
Manage vendors; Plan and coordinate vendor activities
Required Qualifications
Bachelor or Master of Science (required) or higher graduate degree (preferred)
Minimum of 7-10 years of experience in in the medical device/ In Vitro Diagnostics/pharmaceutical industry. 5 yrs in medical/scientific writing
