As the Regulatory Intelligence Manager your role will involve taking responsibility for monitoring the regulatory landscape and providing regulatory intelligence to various stakeholders on applicable regulations standards and best practice guidelines.
Conduct regular monitoring of regulatory environment and identify regulatory intelligence which can affect portfolio and business operations
Develop expertise of local SMEs and provide support in keeping their knowledge up to date
Perform impact assessment of regulatory intelligence and disseminate to affected functions with action owners identified
Manage implementation of actions within reasonable deadlines
Participate in internal and external forums to obtain and share intelligence
Partner with Regional RA functions
Review procedures and templates and take ownership of certain procedures and templates
Your qualification
University degree in a scientific subject such as Biomedical Science Pharmacy Engineering or a similar discipline is essential
You can demonstrate a minimum of 3 years' experience in Medical Device regulatory affairs
Ability to review and interpret legislative text
Confidently lead crossfunctional discussion and drive projects to completion
Ability to communicate and provide training on regulations and company policies and procedures
Effective communication skills and excellent attention to detail
Please note for the benefit of your team and stakeholders; you will be required to work from our UK Head Office in Essex no less than twice per week.
Your competencies
Patient Focus We put patients at the heart of everything
Integrity We do the right thing
Innovation We look for new ways to make things better
Impact We take accountability and get things done
Empathy We care for one another and work together
Your Benefits
In addition to a competitive salary you will receive a generous annual leave entitlement
You will be eligible to receive private medical cover
Comprehensive company pension scheme
You will receive an annual health check with BUPA funded by us
Employee Assistance Program to support your health mental and emotionalwellbeing
At our HQ we have a subsidised staff restaurant and free parking
Other benefits include discounted gym and wellness memberships cashback and discounts with major UK retailers
Further Information
Valuing diverse perspectives and lifestyles is closely aligned with our core values. We would therefore like to encourage all candidates to apply regardless of gender nationality ethnic and social origin religion age disability sexual orientation marital status identity or conditions and restrictions which cannot be shown.
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