- 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.
- 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
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.
Skills Required
- Proven experience in a medical device environment with global regulatory submissions
- Strong knowledge of Medical Device Regulation (MDR) and/or US FDA requirements
- Experience ensuring compliance with ISO 13485, FDA 21 CFR Part 820, cGMP, and cGDP
- Ability to manage multiple projects and priorities with strong attention to detail
- Collaborative approach and ability to provide clear regulatory guidance to stakeholders
- Life sciences degree
Smith & Nephew Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Smith & Nephew and has not been reviewed or approved by Smith & Nephew.
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Healthcare Strength — Medical, dental, and vision plans are paired with a global mental‑health program for employees and families, indicating a robust core health package.
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Retirement Support — U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
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Leave & Time Off Breadth — Generous holiday, paid volunteering leave, and flexible work models point to broad time‑off options.
Smith & Nephew Insights
What We Do
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win.. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Please note: not all products referred to may be approved for use or available in all markets.
