Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
If you are passionate about regulatory affairs and want to play a meaningful role in bringing medical device innovation to patients around the world, this is an opportunity to build your expertise within a collaborative and supportive global environment. As a Regulatory Affairs Specialist 2, you will work across regions, products and teams, contributing directly to the success of our orthopaedics portfolio and helping ensure our technologies meet regulatory requirements worldwide.
What will you be doing?
In this role, you will be part of a collaborative regulatory affairs team supporting both new and existing medical devices. Your work will span global regulatory submissions and sustaining activities for our legacy orthopaedic portfolio. You will partner closely with project teams to shape regulatory strategies, support product changes and maintain compliance throughout the product lifecycle.
- Preparation of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
- Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
- Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
- Provide support for internal and Regulatory agency audits.
- Direct engagement with regulatory authorities as required.
- Complete regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance.
- Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
- Review product labeling to ensure compliance with regulatory requirements.
- Other activities as assigned.
What will you need to be successful?
Success in this role comes from combining technical understanding with strong collaboration and communication. You will bring curiosity, structure and confidence to your work, alongside the ability to manage competing priorities in a fast paced environment.
A bachelor’s degree or equivalent experience, ideally in a scientific or technical discipline, with experience in the medical device industry
Working knowledge of global medical device regulations, standards and guidance, with hands on experience preparing or supporting regulatory submissions
Strong communication skills, including technical writing, and the ability to work effectively with cross functional and international teams
A proactive, analytical and solution focused mindset, with the ability to work independently while contributing positively to a team
You. Unlimited.
We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.
Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about our Employee Inclusion Groups on our website (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
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