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Medical Device Regulatory Affairs Specialist
3 months ago
Job Description Zest Scientific is actively recruiting for a Senior Regulatory Specialist in the field of medical devices for a leading global drug development organization. We are seeking a motivated individual with substantial experience in Medical Device Regulation, particularly in the areas of combination products, drug/device, and in vitro diagnostics (IVDs). Please note, this role cannot offer sponsorship or relocation support.
With a good understanding of the medical devices industry (coupled with some work in the pharmaceutical sector), you will leverage your regulatory knowledge and experience to deliver on required project work.
With broad and comprehensive expertise within the Regulatory environment you will lead project work and partner with the business to solve complex regulatory issues that impact the department or wider business.
An ability to understand scientific and technical information relating to an assigned portfolio of company products.
You will hold a scientific degree
Support the team in ensuring that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature (e.g.: physical devices, digital devices, in-vitro diagnostics, etc)
Continuously monitor the changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new Regulations
ABHI, ABPI, MedTech, etc) working groups and gather regulatory intelligence
Keep track of changes and/or implementation of regulations relevant to medical devices, such as (but not limited to) Sustainability/Environment, etc
Provide support for the implementation/adaptation of the medical device structure across the UK
Provide regulatory advice to project teams
Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance
Advise the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concern the UK
Support the teams in any interaction with the MHRA that concerns medical devices
Provide training to people on medical device regulation and all its related aspects
Provide regulatory expertise on new product development
Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information
Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines
Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise
Review Marketing materials and provide advice to the commercial teams on business-related activities
