A brilliant opportunity for a RA Specialist, with the potential of hybrid work, to join an award-winning global supplier of everyday healthcare essentials.
Act as a Point of Contact for Regulatory Affairs, providing advice as necessary.
Creation and update of Technical Files in accordance with the established schedule and requirements of international standards and directives.
Completion of Regulatory Submissions.
Review and Approve Artwork and Labelling to ensure compliance with applicable regulatory requirements.
Work with the Product Management team to establish and maintain documentation to ensure that company products comply with the relevant regulations (e.g., EU Medical Device Directive, EU Medical Device Regulation, EU Cosmetic Regulation, EU Biocide Regulation, EU Personal Protective Equipment Regulation and Licensed Medicinal Product requirements).
In conjunction with the QA team, support the Post Market Surveillance and Vigilance processes to ensure all regulatory and compliance requirements are met.
Conduct internal audits to continuously improve QMS and processes.
Consistently drive to create and implement new and innovative ways of working.
Educated to HNC/HND level in a relevant scientific field.
A minimum of 2 years' practical experience in Regulatory Affairs in the Medical Device Industry working to applicable European and International standards (e.g. ISO 13485 and ISO 14971).
If you are interested in this role, please contact me on OR 07936 035 256.
Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.
To speak to a recruitment expert please contact Olivia Cann