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Regulatory Affairs Specialist
@GBR - T. J. Smith and Nephew Limited
[Hiring] Regulatory Affairs Specialist @GBR - T. J. Smith and Nephew Limited
Mar 15, 2025 - GBR - T. J. Smith and Nephew Limited is hiring a remote Regulatory Affairs Specialist. 💸 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 involves preparing and supporting both US and international regulatory submissions and strategies for our growing portfolio, specifically focused on our Orthopaedic Reconstruction franchise.
- Ensure products meet all regulatory requirements for global markets
- Develop and implement regulatory strategies for timely product launches
- Prepare global regulatory submissions, including 510(k), PMA, MDR Technical Files, and Annual Reports
- Work closely with project teams to develop regulatory strategies and documentation
- Keep up-to-date with current and upcoming regulations and standards
- Manage databases to ensure only approved products are sold
- Maintain regulatory systems for tracking submissions and metrics
- Review and approve engineering and manufacturing changes
- Develop instructions for use (IFU) content and review compliance materials
- Support International Registrations for the product portfolio
- Use Excel for data analysis and related projects
- Support internal and external audits when necessary
Qualifications
- Bachelor's degree or equivalent work experience, preferably in a scientific or technical field
- 2-3+ years experience in Regulatory Affairs
- Experience in US & EU MDR regulatory requirements
Requirements
- Driven and capable of synthesizing information into practice
- Act ethically, ensuring products are safe and effective
- Creative problem solver with strong critical thinking skills
Benefits
- Generous annual bonus and pension schemes
- Save As You Earn share options
- Flexible vacation and time off
- Paid holidays and paid volunteering hours
- Private health and dental plans
- Healthcare cash plans
- Income protection and life assurance
- Hybrid working model for most professional roles
- Hands-on, team-customized training and mentorship
- Discounts on gyms and fitness clubs
- Salary sacrifice bicycle and car schemes
- 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 15, 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. |
