Senior Regulatory Affairs Specialist
smithnephew
Senior Regulatory Affairs Specialist
smithnephew· GBR - T. J. Smith and Nephew Limited
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.
Stay connected by joining our Talent Community.
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 us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
Explore our website and learn more about our mission, our team, and the opportunities we offer.
Frequently Asked Questions
Is the salary disclosed for the Senior Regulatory Affairs Specialist position at smithnephew?
The salary for this Senior Regulatory Affairs Specialist role at smithnephew is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Regulatory Affairs Specialist position at smithnephew located?
This Senior Regulatory Affairs Specialist role at smithnephew is based in UK - Hull GBU Office. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Regulatory Affairs Specialist role at smithnephew full-time or part-time?
This is listed as a Full time position. It is posted as a Senior Regulatory Affairs Specialist role in the GBR - T. J. Smith and Nephew Limited department at smithnephew.
Which team or department does the Senior Regulatory Affairs Specialist at smithnephew belong to?
This Senior Regulatory Affairs Specialist position is part of the GBR - T. J. Smith and Nephew Limited department at smithnephew. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Regulatory Affairs Specialist position at smithnephew?
Click the "Apply Now" button on this page. You will be redirected to smithnephew's official application portal hosted on workday where you can submit your application directly.
When was the Senior Regulatory Affairs Specialist job at smithnephew posted?
This Senior Regulatory Affairs Specialist position at smithnephew was posted on Jul 7, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Regulatory Affairs Specialist
smithnephew
You'll be redirected to smithnephew's official application page on Workday.