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- Tasks: Lead process improvements and manage regulatory systems for innovative medical devices.
- Company: Smith+Nephew designs tech that enhances lives, operating in 100 countries globally.
- Benefits: Enjoy flexible working, generous bonuses, health plans, and discounts on fitness.
- Why this job: Be a trailblazer in regulatory affairs, shaping the future of healthcare innovation.
- Qualifications: Bachelor's degree in relevant field and experience in regulatory affairs required.
- Other info: Join a diverse community committed to making a positive societal impact.
The predicted salary is between 36000 - 60000 £ per year.
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.
Imagine a role where you\’re not just part of the process, you redefine it. At the heart of our innovative medical devices\’ company, we\’re looking for a trailblazer to join our Regulatory Operations team. This isn\’t your typical regulatory role. This is where strategy meets systems, and data drives transformation.
You\’ll be the architect of smarter, faster, and more compliant regulatory processes. From leading high-impact improvement projects to owning the systems that power our global regulatory function, you\’ll shape how we operate today, and how we evolve tomorrow. Think data metrics, process expansion, system ownership, and cleansing complexity into clarity.
What Will You Be Doing?
- Lead and deliver process improvement initiatives across the Regulatory Affairs organisation.
- Identify inefficiencies and develop strategies to optimise regulatory processes.
- Manage end-to-end project lifecycles, including scope, timelines, deliverables, and risk mitigation.
- Facilitate cross-functional collaboration and ensure alignment with business objectives.
- Own and enhance regulatory systems, including defining user requirements and conducting user acceptance testing.
- Monitor performance metrics to drive continuous improvement and data-informed decision-making.
- Maintain clear, compliant documentation, including standard operating procedures (SOPs), work instructions, and training materials.
- Provide training and support on new systems, processes, and best practices.
- Ensure regulatory processes comply with local, national, and international standards.
- Stay up to date with industry trends and regulatory changes to support ongoing improvements.
What will you need to be successful?
To be successful in this role, you\’ll ideally hold a bachelor\’s degree in a relevant field such as Regulatory Affairs, Engineering, or a related discipline, along with experience in regulatory affairs.
You\’ll bring a solid understanding of regulatory requirements, industry standards, and quality management systems (QMS), including Good Manufacturing Practices (GMP). Experience with regulatory submissions, change control, and compliance documentation is essential.
You\’ll have a proven track record in managing process improvement projects, you should be comfortable working both independently and collaboratively, and confident using data analysis and reporting tools such as Excel or Tableau to support decision-making and continuous improvement.
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 Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (
- Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.
- Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
- Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
- Flexibility: Hybrid Working Model (For most professional roles).
- 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.
#LI-hybrid #LI-BM2.
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We\’re more than just a company – we\’re a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N.
Explore our new website and learn more about our mission, our team, and the opportunities we offer. #J-18808-Ljbffr
Regulatory Affairs Operations Specialist employer: Smith & Nephew
Contact Detail:
Smith & Nephew Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Operations Specialist
✨Tip Number 1
Familiarise yourself with the latest regulatory requirements and industry standards relevant to medical devices. This knowledge will not only help you understand the role better but also demonstrate your commitment to staying updated in a fast-evolving field.
✨Tip Number 2
Network with professionals in the Regulatory Affairs sector, especially those who have experience in process improvement projects. Engaging with industry experts can provide valuable insights and may even lead to referrals or recommendations.
✨Tip Number 3
Showcase your data analysis skills by preparing examples of how you've used tools like Excel or Tableau in past roles. Being able to discuss specific instances where your data-driven decisions led to improvements will set you apart from other candidates.
✨Tip Number 4
Research Smith+Nephew's recent projects and initiatives in Regulatory Affairs. Understanding their current challenges and successes will allow you to tailor your discussions during interviews, showing that you're genuinely interested in contributing to their mission.
We think you need these skills to ace Regulatory Affairs Operations Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, process improvement, and project management. Use keywords from the job description to demonstrate that you meet the specific requirements of the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your skills align with the company's mission of innovation and compliance. Mention specific examples of past projects where you've successfully improved processes or systems.
Showcase Data Skills: Since the role involves data analysis and reporting, emphasise your proficiency with tools like Excel or Tableau. Provide examples of how you've used data to drive decision-making and improve regulatory processes in previous roles.
Highlight Continuous Improvement Experience: Discuss any experience you have with managing process improvement initiatives. Be specific about the methodologies you used and the outcomes achieved, as this will resonate well with the responsibilities outlined in the job description.
How to prepare for a job interview at Smith & Nephew
✨Understand Regulatory Requirements
Familiarise yourself with the specific regulatory requirements relevant to the medical device industry. Be prepared to discuss how your knowledge can help Smith+Nephew maintain compliance and improve processes.
✨Showcase Process Improvement Experience
Highlight your previous experience in managing process improvement projects. Be ready to provide examples of how you've identified inefficiencies and implemented successful strategies to optimise regulatory processes.
✨Demonstrate Data Analysis Skills
Since data drives transformation in this role, be prepared to discuss your proficiency with data analysis tools like Excel or Tableau. Share examples of how you've used data to inform decision-making and drive continuous improvement.
✨Emphasise Cross-Functional Collaboration
This position requires collaboration across various teams. Prepare to discuss your experience working with cross-functional teams and how you ensure alignment with business objectives while facilitating effective communication.
