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- Tasks: You'll ensure our products meet global regulatory requirements and prepare submissions for market approval.
- Company: Smith+Nephew designs innovative medical technology to help people live life without limits.
- Benefits: Enjoy flexible working, generous bonuses, health plans, and discounts on fitness memberships.
- Why this job: Join a passionate team making a real impact in healthcare while developing your career in regulatory affairs.
- Qualifications: A Bachelor's degree and 2-3 years in Regulatory Affairs, with knowledge of US & EU regulations.
- Other info: Hybrid working model available; we value diversity and encourage applications from all backgrounds.
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.
Supporting this work, we\’re looking for a Regulatory Affairs Specialist, where you\’ll play an important role in preparing and supporting both US and international regulatory submissions and strategies for our growing portfolio. This role will be focused on our Orthopaedic Reconstruction franchise, that serves our patients and customers to live Life Unlimited.
This position offers the opportunity for you to develop relationships and true partnerships at S+N and with reviewers. You will own the submission, and the questions from regulatory bodies. To achieve this, will require partnering with others in S+N to ensure that accurate evidence and responses are collated and submitted to the regulatory bodies in a timely manner.
This is ideal for an eager regulatory affairs professional who will implement regulatory activities to support currently marketed devices and new product development.
Join us and play a pivotal role in bringing cutting-edge medical devices to markets worldwide!
What will you be doing?
You will be instrumental in ensuring that our products meet all regulatory requirements for global markets. You will develop and implement regulatory strategies, ensuring timely product launches and compliance with all relevant regulations.
- Preparing global regulatory submissions, including 510(k), PMA, MDR Technical Files, and Annual Reports, covering new and modified devices.
- Working closely with our project teams to develop regulatory strategies, testing requirements, and documentation to ensure timely and approved regulatory submissions.
- Keep up-to-date with current and upcoming regulations, standards, and requirements for facility registration, device listing, import/export, and UDI.
- Managing databases to ensure only approved products are sold and supervise UDI systems.
- Maintaining regulatory systems for tracking submissions, impact assessments, and metrics.
- Review and approve engineering and manufacturing changes to maintain compliance.
- Developing instructions for use (IFU) content with support from core functional leads and review IFUs, Surgical Techniques, and promotional materials to ensure compliance.
- Supporting International Registrations for the product portfolio for all regions.
- Using Excel for data analysis and for data-related projects and activities.
- Supporting internal and external audits when necessary.
What will you need to be successful?
We\’re looking for someone with a Bachelor\’s degree or equivalent work experience, preferably in a scientific or technical field, plus 2-3+ years experience in Regulatory Affairs. You should be experienced in US & EU MDR regulatory requirements.
The ideal candidate for this role is driven and a go-getter, capable of taking information, synthesising it, and putting it into practice effectively. You\’ll be guided by acting ethically, as this notion sits at the heart of our team. This role ensures that products provided to patients are safe and effective, exercising regulations with a foundation of ethics and care. You\’ll be a creative problem solver with strong critical thinking skills, adept at finding solutions where not everything is black and white.
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 (https://www.smith-nephew.com/
- 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.
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.
#LI-remote, #LI-BM2.
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Regulatory Affairs Specialist (Orthopaedic Reconstruction) employer: Smith & Nephew
Contact Detail:
Smith & Nephew Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist (Orthopaedic Reconstruction)
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for orthopaedic devices in both the US and EU. Understanding the nuances of 510(k) submissions and PMA processes will give you a significant edge during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with orthopaedic reconstruction products. Engaging with industry experts can provide insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory standards by following relevant publications and attending webinars. This knowledge will not only prepare you for discussions but also demonstrate your commitment to the field.
✨Tip Number 4
Prepare to discuss real-world examples of how you've successfully navigated regulatory challenges in past roles. Being able to articulate your problem-solving skills will showcase your readiness for the responsibilities of this position.
We think you need these skills to ace Regulatory Affairs Specialist (Orthopaedic Reconstruction)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs, particularly in Orthopaedic Reconstruction. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific experiences that align with the responsibilities outlined in the job description.
Highlight Relevant Skills: Emphasise skills such as critical thinking, problem-solving, and knowledge of US & EU MDR regulations. Provide examples of how you've successfully navigated regulatory challenges in previous roles.
Showcase Your Commitment to Ethics: Since ethics is a core value for Smith+Nephew, include examples of how you have upheld ethical standards in your work. This could be through compliance with regulations or ensuring patient safety in your previous roles.
How to prepare for a job interview at Smith & Nephew
✨Understand Regulatory Requirements
Familiarise yourself with the specific regulatory requirements for both US and EU markets, especially concerning orthopaedic devices. Being able to discuss these regulations confidently will demonstrate your expertise and readiness for the role.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled complex regulatory challenges in the past. Highlight your critical thinking abilities and how you can find solutions in ambiguous situations, as this is crucial for a Regulatory Affairs Specialist.
✨Emphasise Collaboration Experience
Since the role involves working closely with project teams, be ready to discuss your experience in cross-functional collaboration. Share specific instances where you successfully partnered with others to achieve regulatory compliance.
✨Stay Updated on Industry Trends
Demonstrate your commitment to continuous learning by discussing recent changes in regulatory standards or upcoming trends in the medical device industry. This shows that you are proactive and dedicated to staying informed.
