Regulatory Affairs Specialist

Smith & Nephew

Generous annual bonus; pension schemes included; s...
Hybrid
Bachelor's degree in scientific or technical discipline
Hands-on experience preparing regulatory submissions
Working knowledge of global medical device regulations
Smith & Nephew is seeking a Regulatory Affairs Specialist to join their collaborative team, focusing on global regulatory submissions for medical devices in the orthopaedics sector. The ideal candidate will possess strong communication skills and a background in regulatory affairs within the medical device industry

Job Summary

  • This role involves preparing global regulatory submissions including US 510(k) and EU technical documentation for the orthopaedics portfolio.
  • The company offers a flexible hybrid working model along with generous annual bonuses, pension schemes, and share options.
  • Candidates will partner closely with project teams to shape regulatory strategies and ensure technologies meet worldwide requirements.

Matching Summary

Match Score: 85

Smith & Nephew is seeking a Regulatory Affairs Specialist to join their collaborative team, focusing on global regulatory submissions for medical devices in the orthopaedics sector. The ideal candidate will possess strong communication skills and a background in regulatory affairs within the medical device industry.

Salary

Generous annual bonus; Pension schemes included; Save As You Earn share options available

Skills & Requirements

Must-have

  • Bachelor's degree in scientific or technical discipline
  • Hands-on experience preparing regulatory submissions
  • Working knowledge of global medical device regulations
  • Experience with US 510(k) and EU technical documentation
  • Strong technical writing and communication skills

Nice-to-have

  • Proactive analytical and solution focused mindset
  • Ability to manage competing priorities in fast paced environment
  • Collaborative team player with cross functional experience
  • Curiosity and confidence in work approach

Key Requirements

  • Bachelor's degree in scientific or technical field
  • Medical device industry experience required
  • Hands-on submission preparation experience

Work Rights

Not specified

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