Regulatory Compliance Specialist

1 week ago

London, Greater London, United Kingdom Meet Full time
Regulatory Affairs Custom Device Team Lead / Senior Regulatory Affairs Custom Device Associate


Main Purpose of Job and Objectives:nPerform Regulatory tasks to ensure compliance with regulations.nPrepare regulatory documentation and submissions for product approvals.nDevelop regulatory plans/strategies for new products and changes to existing products.nParticipate in Design Control and Risk Management activities.nReview and prepare regulatory paperwork in accordance with international standards and regulations.nReview product packaging, labelling, IFUs, and marketing literature for compliance.nFacilitate compliance with Vigilance System.nProvide regulatory input to functional groups.nParticipate in the review of RA procedures.nReview and approve validation protocols and reports.nMentor RA Associates.nFacilitate in the compilation, communication, and monitoring of FSN and recalls.nPerform other duties as required by the RA department.


Dimensions & Limits of Authority:

nMust work within the requirements of the company handbook and policy statements.nMaintain awareness of the relevance and importance of activities performed and how they contribute to quality objectives.nEnsure accurate completion of records and report any quality issues to the immediate supervisor.nEnsure facility, processes, and documentation remain in a state of audit readiness.


Qualifications & Experience:

nExperience in team/project management/custom-made devices is desired.nExperience with quality engineering and/or MDR is required.nAble to communicate effectively with external parties such as customers and distributors.nAble to communicate effectively with personnel in QA/R&D and other departments.


Company Requirements:
nMust adhere to the company handbook and policy statements.

Quality Requirements:

nMaintain awareness of how activities contribute to quality objectives.nWork within the Quality Management System at all times.nEnsure accurate completion of records and report any quality issues to the immediate supervisor.nEnsure facility, processes, and documentation remain in a state of audit readiness.


EH&S Requirements:

nTake care of your own health and safety and that of others who may be affected by your actions.nWork cooperatively to highlight issues affecting Health and Safety.

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