About this role
What will you be doing?
You will be responsible for overseeing a portfolio of products within the AWC business unit and all aspects of their management this can include:
• Managing project and regulatory involvement with direct management supervision. This includes providing on-going regulatory advice to project teams throughout the product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
• To compile and review, as required, regulatory submissions in accordance with national requirements to ensure appropriateness and consistency in content and presentation of information both within and between registration applications. This can include European Technical Files, US 510(k) applications and device listings as required.
• To complete the requirements of the Smith & Nephew regulatory submission plan per the requirements of RIMSYS (recording/tracking of regulatory submission application).
• To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
• To review and approve change control impact assessments for products.
What will you need to be successful?
- A background in life sciences or similar discipline
- Experience with medical device regulations and submissions
- Strong organisational skills and proficiency in MS applications
- The ability to build effective relationships across teams and with external stakeholders
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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Other facts
About Smith+Nephew
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.
What you'll do
- The Regulatory Affairs Specialist will oversee a portfolio of advanced wound care products, managing regulatory involvement and providing advice to project teams. Responsibilities include compiling regulatory submissions and reviewing product-related documentation for compliance.
Ready to join Smith+Nephew?
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