Selexa Biotech are exclusively partnered with a leading Medical Device client in the search for their next RA Leader.
Our client require an experienced leader, someone capable of delivering robust RA process for the business, as well as leading a team of high-performing and capable Regulatory Affairs Specialists.
As a leader within Regulatory Affairs for the business, you will be responsible for the creation, updating and maintenance of all technical files in support of product updates and maintaining Notified Body CE Certification, FDA clearance, and UKCA marking. This will also include Post Market Surveillance activities.
Role Responsibilities include:
* Contribute to regulatory strategies for new products and design changes to existing products.
* Create and maintain, Technical Files including the Summary Technical Documentation and GSPR Checklists for the UK, Europe, and MDSAP countries as well as 510(k) submissions.
* Implement the transition of certain product types to EU MDR 2017/745 (ensuring technical documentation is compliant and up to date).
* Support the creation and maintenance of Clinical Evaluation Report(s).
* Collate Technical Files for submission to the Notified Body, and contribute to responses to questions as required.
* Coordinate the Post Market Surveillance process for Summit’s range of products.
* Act as RA reviewer/approver for product labelling, packaging artwork, and marketing materials.
* Assi...