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Smith+Nephew

Regulatory Affairs Specialist

Smith+Nephew

Regulatory Affairs Specialist at Smith+Nephew, supporting medical device innovation with global regulatory submissions. Engaging in regulatory compliance and maintaining product registrations.

Posted 5/14/2026full-timeHull • 🇬🇧 United KingdomMid-LevelSeniorWebsite

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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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