Regulatory Affairs Project Manager
5 days ago
About Abbott
At Abbott, we're driven by a passion to improve the quality of people's lives. Our commitment to innovation and excellence has made us a leader in the healthcare industry for over 135 years.
Our Mission
We create new solutions that help people live their best lives through better health. From next-generation diagnostics to life-changing devices, science-based nutrition, and novel reformulations, our diverse global network serves customers in over 160 countries.
Our Team
As the Industry Leader, Abbott Diabetes Care designs, develops, and manufactures glucose monitoring systems for use in both home and hospital settings. Our Centre of Excellence in Witney is 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.
Job Summary
We're seeking a highly skilled Regulatory Affairs Project Manager to join our team in the EMEA region. As a key member of our regulatory team, you will be responsible for setting the EU Regulatory Strategy and overseeing the project management of regulatory projects.
Main Responsibilities
- Ensure strong communication and working relationships with the Alameda RA group and other RA teams globally
- Ensure strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups, and US Project Management
- Support the interface and guidance of external auditors such as FDA and ISO assessors reviewing Technical Files
- Provide leadership on Notified Body strategy and regional/global planning of product registration
- Define the regulatory strategy for product approvals in EU and region
- Support RA compliance with site EHS policy and procedures
- Maintain the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations
Requirements
- Minimum of a bachelor's degree in a relevant field
- Knowledge of regulatory requirements for ISO 13485, EMC, MDD, IVDD, MDR, and FDA Quality Systems Regulations
- Experience within a medical or healthcare manufacturing industry in a regulatory role
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