Title: Medical Writer – Clinical Evaluation Reports
Founded in 1968, Oriel STAT A MATRIX, a Validant company, is a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. We are proud of our focus on client outcomes: we achieve superior client results because we select from a pool of diverse, highly skilled, commercially minded Quality System and Regulatory Affairs team members. Together, our team can execute best-in-class advisory, audit, consulting and training services in the medical/in vitro device market. We are looking for individuals who possess a level of skills, attributes and talents commensurate with our brand.
The position is for a remote, contract medical writer with considerable CER experience under the EU Medical Device Regulations. The post holder will be expected to write, review or restructure documents according to best practice expectations of the various regulatory bodies they will be submitted to. The medical writer works with our regulatory affairs team and has access to all team members. The post holder must be able to explain their rationale for completing the reports to other team members and to our clients.
- Confident personality and competent in getting ideas across to others effectively
- Demonstrates sound critical judgment on the validity of data, data analysis and how to present it
- Highly organized and self-motivated. Capable of completing a task remotely from start to finish
- Outstanding written communication skills and competent in leading software applications that support the industry
- Ability to write at the technical and strategic level and a focus on quality of documents produced
- Bachelor’s degree in Life Sciences or related field; master’s degree preferred
- A career focus in medical or in vitro devices, with related software a major plus
- Evidence of having written in excess of 50 medical reports and having supported multiple medical devices
- Sound practical knowledge working under ISO13485, ISO14971 and the EU MDR
- Sound knowledge of clinical trials process, device usability and a critical eye on potential misuse
- Authoring, updating or rewriting existing regulatory documents including risk management files, clinical evaluation protocols, clinical evaluation reports, training materials, user guides, and instructions for use
- Authoring and modifying documents for regulatory submission
- Ability to quickly assess the critical aspects of any device and any device class as it relates to regulatory submissions
- Handling inquiries from regulatory bodies and the client
- Interrogating datasets to determine their integrity, sufficiency for purpose and ability to meet regulatory audit
Experience with Industry Requirements
- Experience with medical device manufacturing, interpretation and application of codes, regulations, and standards
- Experience with quality systems planning and implementation, design control and process validation
Travel: Occasional travel may be required.
To Apply To apply, email your resume and a cover letter to email@example.com. Please place Job Code: “MWCER” in the subject line.
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Oriel STAT A MATRIX is an Equal Opportunity Employer.