The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally.
As a Regulatory Affairs Category Manager you will build a network of collaborative relationships within the sub-category and LOCs and ensure all regulatory requirements are met for both new innovation and existing products according to GSK Values.
In this role you may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require you to provide specialist regulatory advice across the Category and Function.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Medical devices Accountabilities:
For Medical Devices (all classes according to 93/42/EEC as amended and Medical Device Regulation (EU) 2017/745 as amended) for which the Manager Regulatory Affairs Category is responsible or acting as back-up ensuring among others:
- Acting as a delegate for the Director Category Regulatory Affairs for the approval of technical files together with the Legal Manufacturer representative.
- Approval and Signature of Declaration of Conformities (together with the Legal Manufacturer representative), and other necessary declarations and statements necessary for regulatory activities
- Medical Device technical documentation (MDTF) creation, update and maintenance as per GSK Quality System/Procedures and in the relevant Consumer Healthcare electronic document management system (eDMS) ensuring among others:
- Delivery of regulatory evaluation / strategy and MDTF update in case of non-technical changes (both significant and non-significant). Technical changes are handled by GRA CMC team.
- Regulatory communication with Notified Body, including initial MDTF and input to significant changes submissions, coordination of answers to questions from Notified Body / Competent Authorities / Health Authorities
- Representation of GRA during audits with MDTF or Medical Devices Regulatory activities in scope.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
*Li-GSK
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