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- Tasks: Ensure regulatory compliance for innovative medical devices and lead product registrations.
- Company: Join Biocomposites, a global leader in infection management solutions.
- Benefits: Enjoy competitive salary, pension, discounts, and free travel perks.
- Why this job: Make a real impact in healthcare by transforming lives with cutting-edge products.
- Qualifications: Bachelor’s in life sciences and 2-5 years in medical device regulations.
- Other info: Be part of an inclusive team that values diverse perspectives and growth.
The predicted salary is between 36000 - 60000 £ per year.
Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.
The Regulatory Affairs Specialist is responsible for ensuring regulatory products are registered in accordance with country specific requirements throughout the organisation.
Duties & Responsibilities- Creates and maintains global regulatory submissions to support timelines for new/modified product launches/registrations.
- Leads registrations and submissions for new and existing products.
- Ensures conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Provides Regulatory Affairs support during internal and external audits.
- Liaise with regulatory authorities and Notified Bodies as required.
- Report, assess and communicate any changes in regulations.
- Provides regulatory assessment on complaints.
- Support Regulatory Affairs Manager in creation and maintenance of procedures.
- Act as mentor to junior regulatory staff members.
- Support and act as delegate for activities falling under the remit of the Regulatory Affairs Manager.
- Bachelor’s Degree in a life science or equivalent field.
- Minimum 2-5 Years’ experience within Medical Devices Regulatory or Quality.
- Ability to read and understand medical device regulatory requirements and/or standards.
- Ability to review audit reports and action accordingly.
- Understanding of post market surveillance and/or clinical report writing.
- Ability to prioritise large amounts of changing, complex workload from multiple sources and make timely and effective decisions for the execution of project objectives.
- Takes accountability for the achievement of business goals and objectives.
- Has the ability to work independently.
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits. We grow talent. At Biocomposites we create opportunities to thrive and grow. One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
Who do we look for?People who are passionate about what we do. People who are open minded to evolving the way we work. People who can work together to transform outcomes and change lives.
Benefits- Company events
- Company pension
- Employee discount
- Free or subsidised travel
- Free parking
Regulatory Affairs Specialist in London employer: Biocomposites
Contact Detail:
Biocomposites 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 people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching Biocomposites and understanding their products. Show your passion for infection management and how your skills align with their mission. Tailor your responses to highlight your experience in regulatory affairs.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience with regulatory submissions and compliance clearly.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining the Biocomposites team.
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 relevant experience in medical devices and regulatory compliance, and don’t forget to mention any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background makes you a perfect fit for Biocomposites. Keep it concise but impactful!
Showcase Your Skills: In your application, be sure to showcase your ability to handle complex workloads and make timely decisions. Mention any experience you have with audits or liaising with regulatory authorities, as these are key aspects of the role.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
How to prepare for a job interview at Biocomposites
✨Know Your Regulations
Make sure you brush up on the specific regulatory requirements for medical devices, especially those relevant to Biocomposites. Understanding the nuances of compliance and how they apply to product development will show that you're serious about the role.
✨Showcase Your Experience
Prepare to discuss your previous experience in regulatory affairs, particularly within the medical devices sector. Be ready to share specific examples of how you've successfully managed submissions or navigated complex regulations in past roles.
✨Ask Insightful Questions
During the interview, don’t hesitate to ask questions about the company’s approach to regulatory challenges. This not only shows your interest but also gives you a chance to demonstrate your knowledge and critical thinking skills.
✨Demonstrate Team Spirit
Biocomposites values collaboration, so be prepared to talk about how you've worked effectively in teams. Share examples of mentoring junior staff or collaborating with cross-functional teams to highlight your ability to contribute to their team spirit.
