Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

Regulatory Affairs plays a vital part in the process by ensuring our products are and remain compliant to the needs of the market and needs of patients. Our products are in 100 countries globally, and supporting this takes a huge effort.

To do this, we're looking for aRegulatory Affairs Specialistto support our Advanced Wound Management (AWM) franchise in Hull. They will provide regulatory expertise in the research, development and marketing of our products and ensure that regulatory approvals are obtained and maintained in accordance with the agreed standards.

Please Note: This is a Fixed Term Opportunity until March 2025.

What will you be doing?

Interacting and liaising with Competent Authorities as part of field action, vigilance and post-market surveillance activities for UKINOR Cluster.

Preparing and submitting regulatory applications for the UK (such as product registrations with the MHRA).

Reviewing and approving advertising and promotional material; including product labelling, conference material, and product claims for regulatory compliance.

Establishing importer notification database for the non-UK based third-party manufacturers (including their UKRP details).

Answering technical and regulatory enquiries from customers and/or colleagues to support their business activities and meet requirements.

Submitting Drug Tariff applications and maintain market access (e.g. product registrations) to products and service in the area of responsibility and according to the business plan.

Compiling and approving regulatory dispatches in accordance with national requirements, to ensure consistency in content and presentation of information between registration applications.

Providing expert advice and guidance to internal stakeholder and project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives and interpret individual country legislation.

Interpreting individual country legislation relevant to the S&N AWM business.

What will you need to be successful?

Our successful candidate will be university educated in a scientific discipline and have proven regulatory experience, ideally in a medical device environment. They will be highly organized and a strong communicator with a sound understanding of UK regulations

You.Unlimited.

165 years of groundbreaking innovation requires a steadfast focus on what’s next. We’re passionate about you. You’re what’s next...

Inclusion, Diversity and Equity:Committed to Welcoming, Celebrating and Growing on Diversity, Learn more about our Employee Inclusion Groups () on our website

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.