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- Tasks: Ensure our advanced wound care products meet global standards and regulations.
- Company: Join Smith+Nephew, a leader in innovative healthcare technology.
- Benefits: Generous bonuses, flexible vacation, health plans, and employee discounts.
- Why this job: Make a real impact in healthcare and influence life-changing innovations.
- Qualifications: Background in life sciences and experience with medical device regulations.
- Other info: Enjoy a hybrid working model and excellent career development opportunities.
The predicted salary is between 28800 - 48000 £ per year.
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?
- Managing project and regulatory involvement with direct management supervision. This includes providing ongoing 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.
- 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.
- Complete the requirements of the Smith & Nephew regulatory submission plan per the requirements of RIMSYS (recording/tracking of regulatory submission application).
- Review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
- 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.
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.
Generous annual bonus and pension schemes
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.
Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Explore our website and learn more about our mission, our team, and the opportunities we offer.
Regulatory Affairs Specialist in London employer: Eagleston Financial Group
Contact Detail:
Eagleston Financial Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. Building connections can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by researching Smith+Nephew's products and their regulatory processes. Show us you’re passionate about making an impact in healthcare and how your skills align with our mission.
✨Tip Number 3
Practice your pitch! Be ready to explain how your background in life sciences and experience with medical device regulations make you the perfect fit for the Regulatory Affairs Specialist role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, you’ll find all the latest opportunities and updates about our community.
We think you need these skills to ace Regulatory Affairs Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with medical device regulations and any relevant projects you've worked on. We want to see how your background aligns with our mission!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about healthcare and how you can contribute to our team. Be sure to mention specific skills that match the job description.
Showcase Your Organisational Skills: Since this role requires strong organisational skills, give examples in your application of how you've successfully managed projects or regulatory submissions in the past. We love seeing how you keep things on track!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll get to explore more about our culture and values!
How to prepare for a job interview at Eagleston Financial Group
✨Know Your Regulations
Familiarise yourself with the specific medical device regulations relevant to the role. Brush up on European Technical Files and US 510(k) applications, as these will likely come up in conversation. Showing that you understand the regulatory landscape will impress your interviewers.
✨Showcase Your Organisational Skills
Prepare examples of how you've managed projects or regulatory submissions in the past. Highlight your ability to keep track of multiple tasks and deadlines, as this is crucial for a Regulatory Affairs Specialist. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Build Relationships
Demonstrate your ability to collaborate effectively with cross-functional teams. Think of instances where you've successfully worked with others to achieve a common goal. This will show that you can build the necessary relationships within Smith+Nephew and with external stakeholders.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and how they support innovation in healthcare. This not only shows your interest in the role but also gives you a chance to assess if the company culture aligns with your values, especially regarding inclusion and belonging.
