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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.
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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. |
