Senior Manager, Regulatory Affairs
il y a 3 semaines
Senior Manager, Regulatory Affairs - Medical Devices
Job Type:
Full Time, Permanent Role
Location:
Greater London, UK and select EU regions
Compensation:
Competitive salary and benefits package
We are excited to present a remarkable opportunity within a dynamic pharmaceutical organization specializing in Oncology, Supportive Care, Gastroenterology, and Hepatology.
In response to our expanding operations, we are seeking a Senior Manager, Regulatory Affairs for Medical Devices Lifecycle Management to enhance our team.
As a Senior Manager in Regulatory Affairs, you will oversee the strategic lifecycle management of our medical devices following CE approval, along with the operational execution in collaboration with our Regulatory Service Provider.
Your role will be pivotal as the primary regulatory contact for all inquiries related to our medical device portfolio, offering guidance on regulatory requirements and compliance to various teams within the organization.
- Contributing to discussions regarding projects and inquiries related to medical devices, while proactively addressing complex regulatory challenges.
- Leading and supporting all post-market surveillance initiatives for our medical device offerings across the UK, Europe, and emerging markets.
- Driving the Regulatory Affairs strategies for medical devices on a global scale.
- Overseeing and advising the Regulatory Service Provider on strategies for maintenance and submission of medical devices, including updates to technical files and regulatory submissions for any changes.
- Representing Regulatory Affairs Lifecycle Management for Medical Devices both internally and externally.
- Managing regulatory intelligence for medical devices, including relevant databases.
- A minimum of 8 years of experience in the medical device industry, with a solid understanding of new registrations and post-market surveillance.
- Proficient in maintaining medical devices across global markets.
- Extensive regulatory experience in the medical device sector, with significant exposure at a senior level and comprehensive knowledge of global regulatory standards (including GMP, GLP, and BCP).
- Expertise in the development, certification, and maintenance of medical device products.
- Experience in line management or mentoring roles.
- This position offers the opportunity for the right candidate to advance into a senior role within the organization, taking charge of a growing portfolio of medical devices, accompanied by a competitive salary and benefits.
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