The Role: To provide RA leadership on product lifecycle management (change management) and global product registrations. Provide support for initiating and tracking impact assessments for...
- 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 589626
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.