GXpeople are looking for a Medical writer to join our client on a permanent basis who are a global medical device manufacturer.
This will be a remote position with some travel spread througout the year
The Associate Medical Writer will be responsible for the production of high-quality clinical documentation to support regulatory submissions, maintain compliance activities, support new product development / Design Changes programs, and other projects that may require Clinical participation.
Key Responsibilities: Essential functions of the position include but are not limited to the following, other duties may be assigned.
* The collection, collation, reporting and maintenance of Post Market surveillance data
* Assist in the design and distribution of questionnaires to collect post market clinical follow up data
* Visit customers, trade shows to collect post market clinical follow up data
* Upload the approved documentation into the QMS
* Support the wider Regulatory Affairs team as required
* Identify improvements to the clinical processes and procedures
Qualifications and Personal attributes:
Essential
* Scientific background (BSc or above in Biology, Chemistry, Biomedical Engineering, Life science or related field)
* Expertise in conducting focused literature searches on PubMed, MedLine or other similar literature databases.
* Experience writing PMCF Plans and Reports to comply with EU MDR 745/2017 and the MDCG Guid...