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Regulatory Partner
3 months ago
Job Description Role: Regulatory Partner (Medical Devices)
Hybrid: 2 days on-site
Location: Welwyn Garden City
The Regulatory group works with the wider business to translate the constantly evolving requirements of the UK Regulatory environment into the clients policies, procedures, solutions and strategies that ensure compliance and maximize the value for patients.
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 Be part of Trade Associations (e.g.: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 Affiliate
Provide regulatory advice to project teams (e.g.: Squads, Work Packages, etc) to ensure continued regulatory compliance and timely market release.
Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
Advice 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.
Regulatory Partner (Medical Devices) People :
With a good understanding of the medical devices industry (desirable pharmaceutical industry) and some experience working within a regulated environment, you will leverage your regulatory knowledge and experience to deliver on required foundation work and support with chapter and/or squad work.
With a broad regulatory background and experience, you will have strong Regulatory knowledge and contribute to foundation and/or squad-based work as well as supporting the development of squad/chapter-based plans and goals.
An ability to understand scientific and technical information relating to an assigned portfolio of the clients products.
With broad and comprehensive expertise within the Regulatory environment you will lead foundation work and partner with the business to solve complex regulatory issues that impact the chapter and/or wider business.
An ability to understand scientific and technical information relating to an assigned portfolio of products.
You will hold a scientific degree.
