Regulatory Affairs Specialist (Sports Medicine)
Regulatory Affairs Specialist (Sports Medicine)

Regulatory Affairs Specialist (Sports Medicine)

London Full-Time No home office possible
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Regulatory Affairs Specialist (Sports Medicine)

Join to apply for the Regulatory Affairs Specialist (Sports Medicine) role at Eagleston Financial Group .

Overview

At Smith+Nephew, we design and manufacture innovative technology that enhances lives. Regulatory Affairs is crucial in ensuring our products meet global compliance standards, supporting our mission to help others achieve a Life Unlimited.

We are seeking a Regulatory Affairs Specialist focused on our Sports Medicine franchise in the US. You will prepare and support regulatory submissions for US and international markets, building relationships with regulatory bodies like the FDA.

Responsibilities

  • Prepare global regulatory submissions (510(k), PMA, MDR Technical Files, etc.)
  • Develop regulatory strategies in collaboration with project teams
  • Stay updated on regulations, standards, and compliance requirements
  • Manage databases and supervise UDI systems
  • Review engineering and manufacturing changes for compliance
  • Develop and review instructions for use, technical documents, and promotional materials
  • Support international registrations and audits

Qualifications

  • Bachelor\’s degree or equivalent in a scientific or technical field
  • 2-3+ years in Regulatory Affairs, with experience in Medical Devices
  • Knowledge of US & EU MDR regulations

What We Offer

  • Inclusive, diverse work environment
  • Competitive bonuses, pension schemes, and share options
  • Flexible work arrangements and work/life balance
  • Comprehensive health and wellbeing benefits
  • Training, mentorship, and employee discounts

Application Process

If you\’re passionate about innovation and meet the criteria, we\’d love to hear from you. Join us in making a difference in healthcare worldwide.

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Contact Detail:

Eagleston Financial Group Recruiting Team

Regulatory Affairs Specialist (Sports Medicine)
Eagleston Financial Group
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