Regulatory Affairs Manager, Medical Devices
Jim Gleeson is recruiting for an Regulatory Affairs Manager to join a leading global healthcare organisation, to be based from their offices in Hertfordshire, with some flexible working.
Base salary up to £92K
AsRegulatory Affairs Manager you will ensure the smooth running of activities related to regulatory compliance with UK and European regulations, as well as providing regulatory expertise within the projects in which you are involved.
Key duties will include:
- Managing the regulatory team in charge of all related activities for the UK and Ireland: post-market surveillance, regulatory review of promotional materials, registrations and submissions to authorities
- Ensuring new regulatory requirements are monitored and impact assessed and changes in local procedures to ensure compliance are recommended
- Corresponding and liaison with Regulatory and Quality contacts in EMEA and Corporate to ensure Regulatory & Quality requirements forthe region are met efficiently
- Leading / compiling all materials required in submissions and annual registrations
- Responsibility for Product Field Safety Corrective Actions (FSCA) in the region, including submission, and their efficient and timely execution, including to plan closure as per EMEA region and Corporate plans
- Post Market Surveillance (PMS) activities in the region to enable the EMEA RA and Quality operations to meet their reporting obligations to Regulatory Agencies
As Regulatory Affairs Manager you will require:
- Proven line management experience
- Extensive regulatory affairs experience gained within the medical devices sector
- Strong expertise in UK/IRL and European regulations
- Organizational & project management skills, good communication & interpersonal skills
- Collaborative and positive spirit, adaptability in complex organizations
Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org. Please quote reference 49661 in all correspondence.