Clinical Affaires & Medical Writer Specialist (m/f/x)

Location: Germany-Nürnberg (remote, hybrid or office-based)

Employment Type: Full-time, flexible working hours possible

Consultys Medicals GmbH supports manufacturers to fulfil all regulatory and quality management requirements including clinical affairs to bring their products to market. Additionally, with our sister-company be-on-market, we fulfill all duties as EU legal manufacturers and authorized representative. We are currently seeking a motivated and experienced team player to join our team.

If you are an ambitious and dedicated professional seeking an opportunity to contribute to the advancement of patient safety and make a significant impact in the medical device industry, we would love to hear from you. As a clinical affairs consultant, you will play a fundamental role in managing our clinical evaluation projects. This position offers the flexibility of remote work and/or office-based collaboration, allowing you to work in an environment that suits your needs.

We document patient safety!

Responsibilities: Provide and update documentation in the field of Clinical Affairs for medical devices (e.g. clinical evaluation, post-market clinical follow-up and post-marketing surveillance) Contribute to planning, authoring, updating, and maintaining clinical evaluation plans/reports as well as of PMS plans/reports/ PSURs, PMCF plans/reports, and SSCPs in compliance with EU MDR 2017/745, IVDR 2017/746, MEDDEV 2.7/1 Rev 4 Conducting systematic literature reviews Conduct reviews of CER and PMS documentation to ensure data integrity, accuracy, and compliance with procedures Close cooperation with other medical writers, and with other departments both within the company and on the client’s side Managing daily activities to ensure timelines are met

Qualifications: You have a Masters’ degree, preferably in a science related field (medical engineering or medicine preferred), advanced degree is highly desired You have a minimum of 1-3 years of Clinical/Technical Writing experience in a highly regulated industry You have in-depth knowledge of international regulatory standards related to CER and PMS (e.g., MEDDEV 2.7/1 Rev 4, EU MDR, EU IVDR, MDCG documents) You have scientific/medical writing skills You have experience in literature research You have a goal-oriented and analytical way of thinking You can adapt fast and keep a cool head even in stressful times You are strong, working independent, as well as collaborative within a team You are fluent in written and spoken English, German proficiency is preferable You have excellent communication and interpersonal skills