Overview
Life. Unlimited. At Smith+Neb where we design and manufacture technology that takes the limits off living. As a Senior Regulatory Affairs Specialist you will play a critical role in bringing innovative wound management products to market, ensuring compliance and helping to improve patient outcomes worldwide. Based in Hull, this is an exciting opportunity to work at the heart of a collaborative, forward‑thinking team where your expertise will directly impact business success.
Responsibilities
- 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.
Qualifications
- 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.
- Collaborative approach, with the confidence to provide clear regulatory guidance to diverse stakeholders.
- Life sciences degree may be advantageous.
Benefits
- Generous annual bonus and pension schemes.
- Hybrid working model for most professional roles.
- Private health and dental plans, healthcare cash plans, income protection, life assurance and more.
- Training: hands‑on, team‑customised, mentorship.
- Flexibility: paid holidays, paid volunteering hours, flexible vacation and time off.
- Employee discounts: gyms, fitness clubs, bicycle and car schemes, and more.
- Share options through a Save As You Earn scheme.
About the Company
Smith+Neb is a global medical technology company that designs and manufactures 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.
Senior Regulatory Affairs Specialist employer: Smith & Nephew
Smith & Nephew is an exceptional employer that values clinical expertise and fosters a supportive work culture for its Wound Care Field Specialists. With flexible working options, comprehensive training, and opportunities for professional growth, employees are empowered to make a meaningful impact in the healthcare sector while enjoying a rewarding career in the North Wales and Midlands region.
