The Role:Perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, focusing on Module 3.Committed...
Responsible to lead the timely delivery of all post launch/approval regulatory activities required to ensure that existing products within the Portfolio are maintained on the market in compliance with applicable regulations.
You will work with other regulatory groups and business stakeholder functions to maintain regulatory compliance of our products across the EU and Global markets.
Wide stakeholder evolvement across Category R&D, HME, SSG, Local affiliates, Supply and Marketing
As a Regulatory Senior Associate, you will be responsible to lead and execute the successful delivery of post approval/post launch maintenance activities and projects in line with the approach agreed with your line manager and in compliance with the departmental Standard Operating Procedures.
Ensure that all required registration and regulatory activities are completed in the appropriate and agreed timeframes to protect our existing business.
Educated to degree level in a scientific field or equivalent experience
Industry gained Regulatory Experience and knowledge within Medical Devices.
Experience across Medical Device Classes I-III
Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration
Experience in Post Approval Regulatory including preparing and submitting dossiers, variations and renewals.
Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
High level of accuracy in reviewing and authoring documentation If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.