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About the job
Job Title: RA Specialist
Salary: £35,000 - £45,000
I am currently working with a Medical Device company based in Berkshire who are looking for an RA Specialist to join the team on a permanent basis.
Interviews will be taking place 1 st and 2 nd Week of January.
Some of the role's main responsibilities of the RA Specialist include:
- Product Field Safety Corrective Actions (FSCA) in the region, including sign-off, and their efficient and timely execution, including to plan closure as per EMEA region and Corporate plans
- Post Market Surveillance (PMS) activities in the region to enable the EMEA RA and Quality operations to meet their reporting obligations to Regulatory Agencies
- Be, as necessary, a point of contact for the UK and Ireland Regulatory Agencies in respect to FSCA's, Vigilance and Post Market Surveillance issues
- Regulatory and Quality compliance for the region through appropriate documentation and filing in respect to RA and Quality regional activities (egs FSCA's, Vigilance and PMS)
- If necessary, escalate RA and Quality issues to senior management level ensuring awareness
- Correspond and liaise with Regulatory and Quality contacts in EMEA region and Corporate, to act pro-actively to ensure Regulatory requirements for the region are met efficiently
- As necessary develop and execute local RA initiatives/activities in line with Corporate and EMEA region and Quality requirements.
- Provide training and education on Regulatory Affairs topics both internally and externally as required
- Country and European Regulatory knowledge is maintained and developed through own initiatives and Trade Association and Industry meetings/conferences
If this is something that you think could be of interest then please do get in touch by applying online and give Jack Lundgren a call on ##### ######.