Job Description
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you passionate about making a real impact in healthcare? Join us as a Regulatory Affairs Specialist and play a key role in ensuring our advanced wound care products meet global standards. This is your chance to influence innovation and help deliver life-changing solutions to patients worldwide.
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?
Success in this role means being proactive, detail-oriented, and collaborative. You’ll need:
* 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
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
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