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Regulatory Affairs Associate (Graduate Level) - Remote

Posted 2 days ago

U.S.N

USA - Smith & Nephew

All others
Full Time
Worldwide

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Overview

The Regulatory Affairs Associate at Smith+Nephew plays a crucial role in ensuring that medical devices meet regulatory requirements for global markets, contributing to high impact projects and optimizing processes in a collaborative team environment.

In Short

  • Ensure compliance of products with regulatory requirements.
  • Support development and implementation of regulatory strategies.
  • Author and compile product submissions and technical files.
  • Provide regulatory inputs for cross-functional projects.
  • Assess regulatory impact of changes to existing devices.
  • Support regional registration and renewal requests.
  • Author labeling literature and review advertising materials.
  • Support technical file and quality audits.
  • Collaborate with a diverse team to innovate processes.
  • Engage with various stakeholders in the medical device industry.

Requirements

  • Bachelor's degree or equivalent experience in a scientific or technical field.
  • Passion for learning and curiosity about regulatory affairs.
  • Confident and driven to do the right thing.
  • Ability to engage and work well with diverse teams.
  • Strong communication and documentation skills.
  • Understanding of medical device regulations.
  • Experience in regulatory submissions is a plus.
  • Ability to assess changes for regulatory impact.
  • Detail-oriented with strong analytical skills.
  • Commitment to diversity and inclusion in the workplace.

Benefits

  • Pension Schemes and Save As You Earn share options.
  • Flexible Holidays and Time Off.
  • Paid Holidays and Paid Volunteering Hours.
  • Healthcare Cash Plans and Life Assurance.
  • Hands-On, Team-Customised Training and Mentorship.
  • Discounts on Gyms and fitness clubs.
  • Salary Sacrifice Bicycle and Car Schemes.
  • Employee discounts on various services.
  • Supportive and inclusive work environment.
  • Opportunities for career advancement.

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