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We are constantly looking to add to our core talent. If you are seeking a challenging and rewarding career in a diverse and dynamic work environment, Haemonetics is your employer of choice.
Job Details
Job Description
This position is responsible for creating scientific and regulatory documents while working with a cross-functional team in accordance with the highest quality standards. The Senior Medical Writer prepares and maintains Clinical Evaluation Reports and/or Performance Evaluation Reports for CE technical documentation, complying with EU Medical Device Regulations (MDR), EU In Vitro Diagnostics Regulations (IVDR), and related guidance documents (e.g., MEDDEV 2.7/1 Rev. 4). This involves analyzing safety and performance data for medical devices/in vitro diagnostics and preparing clinical data documents supporting regulatory submissions in the EU, US, and other markets.
The Senior Medical Writer also assists with writing and reviewing regulatory documents related to clinical investigations and other post-market activities.
Responsibilities
* Create and maintain 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).
* Draft protocols, safety plans, and reports in collaboration with Medical and Regulatory Affairs.
* Support Medical and Regulatory Affairs in developing and executing regulatory strategies.
* Manage vendors; plan and coordinate vendor activities.
Required Qualifications
* Bachelor’s or Master’s degree in Science or higher.
* 7-10 years of experience in the medical device, In Vitro Diagnostics, or pharmaceutical industry, with at least 5 years in medical/scientific writing.
* Experience managing external vendors or contingent workers.
* Strong scientific writing skills with attention to detail.
* Proficiency in scientific literature review and data analysis using modern technology.
* Basic knowledge of biostatistics and medical applications related to Haemonetics products.
* Organized, self-driven, with project management skills for multi-product writing portfolios.
* Excellent English language skills; knowledge of other EU languages is a plus.
Employment details and additional company information follow, including seniority level, employment type, and industry sectors.
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