Smithnephew·1 month ago
1 month ago
Senior Regulatory Affairs Specialist
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About this role
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you ready to take your regulatory expertise to the next level in a truly global role? As a Senior Regulatory Affairs Specialist, you will play a critical role in bringing innovative wound management products to market, ensuring compliance and helping to improve patient outcomes worldwide. Based in Hull, this is an exciting opportunity to work at the heart of a collaborative, forward thinking team where your expertise will directly impact business success.
What will you be doing?
- Manage a portfolio of products within the Advanced Wound Care business, ensuring regulatory compliance throughout the product lifecycle.
- Prepare, review, and approve regulatory submissions, including technical files and market registration applications, in line with global regulatory requirements.
- Partner with cross-functional project teams to provide expert regulatory guidance during product development, product changes, and process improvements.
- Lead regulatory activities for new product development projects, ensuring requirements are identified, planned, and delivered to support successful product launches.
- Liaise with regulatory authorities and external stakeholders to secure approvals and maintain product registrations.
- Review and approve product labelling, artwork, promotional materials, and change control assessments to ensure compliance with applicable regulations.
- Drive compliance with quality and regulatory standards, including ISO 13485, FDA 21 CFR Part 820, cGMP, and cGDP requirements, while supporting continuous improvement and knowledge sharing across the team.
What will you need to be successful?
Success in this role comes from combining technical expertise with strong collaboration and a proactive mindset. You will thrive by confidently navigating regulatory requirements while supporting project teams and business objectives.
- Proven experience within a medical device environment, particularly with global regulatory submissions
- Strong knowledge of Medical Device Regulation and or US FDA requirements
- Ability to manage multiple projects and priorities while maintaining attention to detail
- A collaborative approach, with the confidence to provide clear regulatory guidance to diverse stakeholders
- Life sciences degree may be advantageous
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.
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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Company
Smithnephew
Hull GBU Office, United Kingdom
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