Clinical Affairs Specialist Jobs in MA, USA

Clinical Affairs Specialist

  • Plymouth, MA, USA 
5 to 5 years
Full Time
Job Description

You have an academic degree in (life) sciences Ideally, you have at least several years of previous professional experience in a regulated environment such as the medical device industry in Regulatory Affairs, Quality, or Clinical Affairs Ideally, you have a comprehensive knowledge of European Clinical Evaluation guidelines and regulations (MEDDEV 2.7/1 Rev.4, EU MDR, MDCG guidelines) You have sound experience in scientific/medical writing demonstrated by authorship of scientific publications, or through similar professional experience You have excellent communication skills; full professional proficiency in English is required You have a proactive mindset. You are a convincing communicator and are not afraid to suggest improvement possibilities Within our Clinical Affairs team, you take responsibility for projects involving the gathering and structuring of clinical evidence with a global focus. Defining the clinical strategy for our medical devices and documenting Clinical Evaluation plans and reports Creating and maintaining up to date of Post-Market Surveillance Plans and Reports Performing systematic literature search to analyze the available clinical literature for a variety of medical devices You plan, implement, and execute the operational side of clinical investigations, communicating with your Clinical Affairs and Regulatory Affairs colleagues, and collaborating closely with product and market managers. You interact with all required external parties (hospitals, surgeons, authorities) involved in the projects and studies You interact with internal parties (Risk management, R&D, Regulatory Affairs, Marketing, Product Management, Quality Management) to close the loop with clinical evaluation and post-market surveillance and drive action and improvement where needed You write and review documentation in line with applicable requirements, such as EU Medical Device Regulation (EU MDR). You follow up on industry trends and developments to continually update the clinical evaluation plans, and our governing procedures

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