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Posted 2 days agoRegulatory Affairs Specialist
Uk Hull Gbu Office, United KingdomHybrid
Responsibilities
- Review product labeling to ensure compliance with regulatory requirements.
Requirements
- Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
- 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.
- 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.
Benefits
- 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.
- Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts Stay connected by joining our Talent Community .
Additional details
- 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.
- Provide support for internal and Regulatory agency audits.