Abbott Laboratories - Project Manager Regulatory
Abbott Laboratories Witney
About Abbott
Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, more than 113,000 of us are working together in advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
At Abbott, you can help shape the future of healthcare whilst shaping your career.
As the Industry Leader, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes.The site, and its Statistics team, has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System and continues to work on a strong pipeline of products in development. We are passionate about doing work that improves the quality of people’s lives.
Joining us, you can do work that truly matters.
We currently have an exciting opportunity for a RA Project Manager.
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.
Main 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
Requirements:
- 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.
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