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Regulatory Affairs Associate
@GBR - T. J. Smith and Nephew Limited
[Hiring] Regulatory Affairs Associate @GBR - T. J. Smith and Nephew Limited
Mar 16, 2025 - GBR - T. J. Smith and Nephew Limited is hiring a remote Regulatory Affairs Associate. 💸 Salary: unspecified. 📍Location: UK.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
This role will be part of a collaborative and energetic team working on regulatory submissions and compliance maintenance for Smith+Nephew. This role provides an exciting opportunity for someone to innovate and optimise processes as well as contribute to high impact projects within the medical device industry.
- Ensure that our products meet all regulatory requirements for global markets.
- Support in the development and implementation of regulatory strategies, ensuring timely product launches and compliance with all relevant regulations.
- Author and compile product submissions and technical files.
- Support cross-functional projects by providing regulatory submission/compliance strategy documents, regulatory inputs, and documentation reviews (such as clinical evaluation reports, in vitro diagnostic validation, and risk management documentation).
- Assess changes to existing devices (including change requests, supplier changes, and manufacturing transfers) for regulatory impact and submit or support regional change submissions.
- Support regional registration and renewal requests.
- Author labeling literature (such as instructions for use and patient implant leaflets), review package labeling, and review advertising/promotional material.
- Support technical file and quality audits.
Qualifications
- Bachelor's degree or equivalent experience, preferably in a scientific or technical field.
Requirements
- Passion for learning and a genuine curiosity to know more.
- Confidence and drive to do the right thing.
- Enjoy engaging and working with lots of people.
Benefits
- Pension Schemes, Save As You Earn share options.
- Flexible Holidays and Time Off, Paid Holidays and Paid Volunteering Hours.
- Healthcare Cash Plans, Life Assurance and much more.
- Hands-On, Team-Customised Training, Mentorship.
- Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.
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| 📍 | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
unspecified
|
Remote
Location
UK
|
|
Job Type
full-time
|
Posted
Mar 16, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
