Regulatory Affairs Specialist

Smith & Nephew; Hull and East Yorkshire; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global medical technology company is seeking a Regulatory Affairs Specialist to lead regulatory strategy and compliance efforts. You will manage projects from concept to market while ensuring product approvals and compliance with medical device regulations. Ideal candidates should have a background in life sciences, strong organizational skills, and be proficient in MS applications. The role offers a hybrid working model and various employee benefits, promoting work-life balance and inclusion.

Benefits

Generous annual bonus

Pension schemes

Flexible vacation and time off

Private health and dental plans

Discounts on gyms and fitness clubs

Qualifications

• Proactive, detail-oriented, and collaborative.
• Experience in regulatory affairs for medical devices.

Responsibilities

• Guide projects from concept to market.
• Ensure compliance and secure approvals for products.
• Review technical files and US 510(k) submissions.
• Advise on labeling and promotional materials.

Skills

Background in life sciences or similar discipline

Experience with medical device regulations and submissions

Strong organisational skills

Proficiency in MS applications

Ability to build effective relationships across teams

Job description

Regulatory Affairs Specialist page is loaded## Regulatory Affairs Specialistlocations: UK - Hull GBU Officetime type: Full timeposted on: Posted Todayjob requisition id: R86922**Life. Unlimited.** At Smith+Nephew we design and manufacture technology that takes the limits off living.You’ll be at the heart of our regulatory strategy, guiding projects from concept to market. Working closely with internal teams and external partners, you’ll ensure compliance and secure approvals that keep our products moving forward. From reviewing technical files and US 510(k) submissions to advising on labelling and promotional materials, your expertise will shape the success of our wound management portfolio.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 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 discountsStay connected by joining our .We're more than just a company - we're a community! Follow us on to see how we support and empower our employees and patients every day. Check us out on for a glimpse behind the scenes and a sneak peek into **You. Unlimited.**, life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.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.