Summary of post:
We are currently working on a Regulatory Affairs 6 month initial FTC for our Medical Device clients based in Essex.
The role will support local registration activities as well as post-market surveillance activities related to reporting of product adverse events (PAE) to competent Authorities.
Key Result Areas:
* Product registration support: provide the necessary technical documentation and notarised/legalised documentation to regional S-BCs to support them in the registration activities required for submissions to the Competent Authorities where our client intends to market their products.
* Post-Market Surveillance: ensure continued compliance to all relevant regulatory requirements regarding timely reporting of product adverse events (PAE) to Competent Authorities.
* Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
* Support and generate updated technical documentation for product registration purposes.
* Report adverse events in a timely manner to Competent Authorities when applicable.
* Manage and implement Field Safety Corrective Actions and provide feedback to Competent Authorities where required.
* Manage Engineering Change Request (ECR/ECO) process including notification to S-BCs of changes which are notifiable under regulations.
Other Related Duties:
* Liaise with internal and external resources to ensure timely delivery.
* Participate in Continuous Improvement activities
* Undertake any assignment or duty as required by business needs.
* Training of internal stakeholders and other RAQA resources.
* Creation and maintenance of Standard Operating Procedures (SOPs).
* Meet both internal lead times and regulatory timelines for reporting PAE (initial MIRs, follow-up MIRs and final MIRs as required).
* Where required, act as RA back-up for reporting and completion of FSN/FSCA.
Qualifications & Experience:
* University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.
* Minimum of 1 year of experience in regulatory affairs, quality or R&D in the medical device or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.
* Good understanding of EU MDD/MDR, ISO 13485 requirements and ability to communicate these technical and regulatory documents to a less specialist audience.
* Knowledge of medical devices, post-market surveillance, quality compliance.
* Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point)