Senior Regulatory Counsel - Medical Devices & AI
Senior Regulatory Counsel / Regulatory Counsel - focused on Medical Device and AI Regulation - Hybrid in London.
We have been instructed by BSI to source a new Senior Legal Counsel for their Regulatory Services division, to be based in London.
The Regulatory Services Division provides certification services for medical devices across a range of global schemes, and BSI is a full scope EU Notified Body and UK Approved Body. It is also expanding to offer assessment services for products incorporating AI and is one of the first certification bodies to be accredited to offer ISO 42001. BSI will become an EU AI Notified Body in the EU under the AI Act.
The role reports to the General Counsel of Regulatory Services & AI while also working directly with the Head of the RS division. Advising a highly capable and professional team, you will hold a position of critical influence within the business, providing an opportunity to positively shape regulation and legislation within the industry.
You will require a core understanding of UK & European legislation relating to Medical Devices resulting in a strong technical knowledge of MDR, IVDR & MDD. Due to how niche this skillset is, you will likely be coming directly from a law firm that has a life sciences regulatory practice.
In addition, you will:
1. Have (ideally) a minimum of 2 years post-qualification experience (if you have strong technical knowledge of MDR, IVDR & MDD you can have less). This role will also consider up to 10PQE.
2. Have experience of advising in the context of UK and European legislation relation to medical devices.
3. Ideally have knowledge and experience of AI, particularly in a life sciences context.
4. Have the ability to negotiate, communicate effectively and positively influence decision-making with government agencies around the world.
5. Have the ability to effectively communicate in an international environment and the gravitas to advise various stakeholders at all levels.
This is a specialist position. Please only apply if you match the above criteria.
Please note our advertisements use PQE/salary levels purely as a guide. However, we are happy to consider applications from all candidates who are able to demonstrate the skills necessary to fulfil the role. Please note that your personal information will be treated in accordance with our Privacy Policy.
If this role sounds of interest, please apply directly or drop Albert Toms an email at alberttoms@taylorroot.com.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Medical Equipment Manufacturing
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