Job Description
Primary Function of Position:
Act as a representative of Intuitive Surgical Ltd (UK Responsible Person), importer and distributor under the UK medical device regulations. Management of regulatory operations, post-market surveillance, QMS, liaison with Corporate & global RAQA teams, advocacy with government bodies and manufacturer associations across assigned markets (Especially UK and Ireland). Ensure proper liaison with sales, marketing and service teams as well as all other enabling functions.
Roles and Responsibilities:
Regulatory Compliance & Quality System
* Fulfill the role of UK Responsible Person contact and site management representative
* Responsible for ensuring compliance of the quality system activities (Nonconformance management, audit/inspection, economic operator obligations, post market surveillance) in the target markets
* Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
* Stay informed about regional regulatory changes and updates, and implement necessary adjustments to the QMS.
Business Support
* Join the leadership team to ensure compliance of all Intuitive Surgical Ltd activities with applicable regulation; guide and influence operational decisions accordingly
* Represent Intuitive Surgical with competent authorities (eg MHRA, HPRA) and manufacturer associations (eg ABHI, IBEC) to develop and strengthen partnerships, and monitor and implement regulatory trends
* Support public procurement activities and customer satisfaction by ensuring timely and accurate RAQA input
Additional activities
* Other projects may be assigned as necessary
* Travel: up to 20%
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