Regulatory Affairs Associate (Graduate Level)

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living!

We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited. Long before any of this is possible, we have to go through many steps that will validate and verify our products.

Regulatory Affairs plays a vital part in the process! Ensuring our products are and remain compliant to the needs of the market, and needs of patients. Our products are in 100 countries globally, and supporting this takes a huge effort.

This role will be part of a collaborative and energetic team working on regulatory submissions and compliance maintenance for Smith+Nephew. This role provides an exciting opportunity for someone to innovate and optimise processes as well as contribute to high impact projects within the medical device industry.

What will you be doing?

You will be instrumental in ensuring that our products meet all regulatory requirements for global markets. You will support in the development and implementation of regulatory strategies, ensuring timely product launches and compliance with all relevant regulations.

• Authoring and compiling product submissions and technical files.
• Supporting cross-functional projects by providing regulatory submission/compliance strategy documents, regulatory inputs, and documentation reviews (such as clinical evaluation reports, in vitro diagnostic validation, and risk management documentation).
• Assessing changes to existing devices (including change requests, supplier changes, and manufacturing transfers) for regulatory impact and submit or support regional change submissions.
• Supporting regional registration and renewal requests.
• Authoring labeling literature (such as instructions for use and patient implant leaflets), review package labeling, and review advertising/promotional material.
• Supporting technical file and quality audits.
  
  
  

What will you need to be successful?

We're looking for someone with a Bachelor's degree or equivalent experience, preferably in a scientific or technical field.

We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients. To this end, we are looking for someone with a passion for learning and a genuine curiosity to know more. The ideal candidate is confident, driven to do the right thing, and enjoys engaging and working with lots of people.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Growing on Diversity, Learn more about our Employee Inclusion Groups on our website
• Your Future: Pension Schemes, Save As You Earn share options.
• Work/Life Balance: Flexible Holidays and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
• Your Wellbeing: Healthcare Cash Plans, Life Assurance and much more.
• Training: Hands-On, Team-Customised, Mentorship.
• Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts
  
  
  

Applications:

If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.

We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients.

We value the diversity of our people and welcome applications from everyone.

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