Regulatory Affairs Manager

Regulatory Affairs Manager

Abbott Diabetes Care

Witney, Oxfordshire

Competitive Salary + Excellent Benefits

Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people’s lives.

We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.

Primary Job Function

You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.

You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.

Core Job Responsibilities

• Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.

• Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.

• Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.

• Provides leadership on Notified Body strategy and regional/global planning of product registration.

• Responsible for defining the regulatory strategy for product approvals in EU and region.

• Each new development project (product) requires a regulatory strategy to be created and maintained.

• Responsible for supporting RA compliance with site EHS policy and procedures.

• Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.

• Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.

Position Accountability / Scope

• Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.

• This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.

• Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.

Minimum Education

• Minimum of a Bachelor’s degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.

Minimum Experience/Training Required

• Minimum of a bachelor’s degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
• Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
• Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
• You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
• You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.

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