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Regulatory Affairs Specialist
Smith+NephewRegulatory Affairs Specialist at Smith+Nephew, supporting medical device innovation with global regulatory submissions. Engaging in regulatory compliance and maintaining product registrations.
About the role
Key responsibilities & impact- Part of a collaborative regulatory affairs team supporting both new and existing medical devices
- Preparation of global regulatory submissions, including US 510(k) and EU technical documentation
- Work closely with project teams to develop regulatory strategies
- Maintain a working knowledge of global regulations, standards, guidance documents
- Provide support for internal and Regulatory agency audits
- Direct engagement with regulatory authorities as required
- Complete regulatory change assessments to determine impact on registrations
- Develops and maintains company Standard Operating Procedures (SOPs)
- Review product labeling to ensure compliance
Requirements
What you’ll need- A bachelor’s degree or equivalent experience, ideally in a scientific or technical discipline
- Working knowledge of global medical device regulations, standards and guidance
- Hands-on experience preparing or supporting regulatory submissions
Benefits
Comp & perks- 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
- Life Assurance
- Discounts on Gyms and fitness clubs
- Salary Sacrifice Bicycle and Car Schemes
- many other Employee discounts
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsUS 510(k)EU technical documentationregulatory strategiesregulatory change assessmentsStandard Operating Procedures (SOPs)product labeling compliance
Soft Skills
collaborationcommunicationproblem-solving
Certifications
bachelor’s degree