About This Role
This role involves developing and creating clinical, scientific, and regulatory documents for clients, ensuring compliance with various medical device regulations. It suits a professional with medical writing experience who can conduct literature reviews, analyze product complaints, and interpret information from diverse sources.
Responsibilities
- Assess all clinical data related to medical devices/IVDs and evaluate for sufficient evidence to verify scientific validity, clinical performance, safety, and conformity to relevant regulatory standards
- Prepare, write, edit, and review regulatory clinical regulatory reports, such as clinical and performance evaluations, post-market surveillance, and clinical study reports
- Perform literature searches for safety and performance and/or state of the art (SotA) and review for specific medical devices
- Collaborate with cross-functional teams to gather, analyze, and interpret clinical and safety data
- Stay current with existing and proposed global regulations and guidance associated with clinical research, and relay their impact internally and with clients
- Ensure documents are produced in accordance with RQM+ procedures and internal and external guidelines (e.g., MEDDEV 2.7.1 Rev. 4, PRISMA 2020)
- Interact and collaborate with RQM+ clients
Requirements
- Reside in the UK
- 0-2 years of experience
- Bachelor's Degree, Master's Degree, or Ph.D.
- Experience in medical writing in the healthcare industry or academia, or in a related area, such as quality, regulatory, clinical research, or product support
- Strong medical and technical writing skills
- Familiarity with research software and databases (e.g., Endnote, PubMed)
- Strong scientific writing skills with attention to detail
- Ability to work independently as a self-starter, demonstrating initiative and accountability
- Excellent organizational skills to manage multiple projects and meet strict timelines
- Self-motivated individual with a lead by example approach that endorses the company’s core values and culture
- Working understanding of the RQM+ business, organization roles and responsibilities, the internal quality system, and operating systems and how to effectively maneuver within each preferred
- Scientific or technical background
- Strong analytical, diagnostic, consulting and problem-solving skills and ability to tailor solutions to meet the needs of clients
- Strong desire for continuous learning
- Strong oral and written communication skills, including presentation skills
- Excellent interpersonal, communication and influencing skills and ability to work with clients and employees within the medical device industry
