Date added: 31 May 2022
Deadline for applications: 17 June 2022
ResponsibilitiesIntrinsic to the Compliance team, you will be responsible for the creation and maintenance of product technical files to ensure compliance to all legal requirements in line with regulations as well as administrative duties to ensure product and Company compliance to FCA regulations, UKCA marking and UK MDR with following remit:
- Ensure that the conformity of the devices is appropriately verified, in accordance with Silvalea’s quality management system.
- Establish, document, implement, and ensure the quality management system is kept up to date and continually improved in the most effective manner.
- Provide advice to the Silvalea Management team regarding best practice and changes in regulatory affairs.
- Ensure technical documentation and the EU declaration of conformity are drawn up and kept up to date.
- Assist with post market surveillance obligations.
- Liaise with the Technical Team Leader in the reporting and recording of incidents, CAPA, product recalls and field safety notice actions to ensure that vigilance reporting are fulfilled.
- Liaise with Regulatory Authorities and Authorised Representative as required.
- Liaise with and assist notified body to ensure Company compliance is maintained and updated as necessary along with assistance in their audit.
- Objectively review and evaluate Silvalea’s business processes and procedures (IMS).
- Make recommendations on how to improve internal controls and governance processes.
- Assist with internal and supplier audits on behalf of the business as and when required.
- Ensure Silvalea remains compliant with GDPR obligations, addressing breaches and liaising with authorities as required.
- The role requires you to be disciplined, self-motivated with creative thinking, a cheerful disposition, excellent interpersonal skills, and problem-solving abilities.
- Knowledge of medical device compliance requirements would be an asset as you could hit the ground running, but full training will be provided for the right candidate.
- This is an exciting opportunity working with a great team for a busy and highly respected global business with scope for personal growth.
- Applications are accepted on both Full-time and Part-time basis.
To apply for this position, please send your CV and a cover email to Teri Allerton, General Manager: firstname.lastname@example.org.