Excellent opportunity for an experienced Regulatory Affairs professional with extensive knowledge of global market clearance procedures as well as electromedical and disposable standards compliance. The successful applicant will:
Coordinate product market clearance activities (notification, registration, licensing) on a global scale excluding US for the Infusion (solution administration pumps and disposables sets) business
Prepare regulatory submission documents for national authorities
Prepare technical documentation in support of multinational conformity assessment procedures
Support local manufacturing engineering projects through proactive identification and implementation of relevant Standards and Regulations (IEC 60601-1, 3rd Edition and others)
Issue monthly activities report
Support complaint investigation and risk management activities in the absence of the Manager, Compliance and Regulatory Affairs International
Qualifications:
Previous experience in a regulatory affairs role
Previous experience with CE marked electromedical devices
Experience with plastic materials and disposable devices will be a plus
Knowledge of International Medical Devices regulations, IEC 60601-1, ISO 14971, ISO 13485, etc
Educated to degree level preferred
Desirable Skill & Attributes
Excellent organizational skills
Able to work autonomously as part of a multisite team
Effective communicator
Attention to detail
Excellent written and verbal skills
Ability to work with sensitive information in a confidential manner
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.