At a Glance
- Tasks: Support innovative projects by ensuring compliance with global regulatory standards.
- Company: Join a leading consultancy known for breakthrough innovation and quality management.
- Benefits: Gain diverse experience, develop leadership skills, and enjoy a collaborative work environment.
- Other info: Opportunity to grow in a dynamic team with a focus on continuous improvement.
- Why this job: Make a real impact in regulatory affairs while working across various industries.
- Qualifications: Experience in compliance and strong communication skills are essential.
The predicted salary is between 36000 - 60000 £ per year.
We are looking for a Regulatory Affairs Specialist to join us, working across multidisciplinary teams to support and enable breakthrough innovation.
At Cambridge Consultants, our approach to quality applies technical expertise to provide a platform which encourages and facilitates creativity and innovation to meet global regulatory requirements. The QA Group is responsible for maintaining the quality management system that supports our business processes, complies with regulatory requirements, and satisfies our clients' expectations.
Your role will focus on providing company-wide regulatory support to our project teams, spanning both medical and non-medical disciplines, as well as supporting the QA Director and Regulatory Affairs Manager with operational activities of the Quality Management System and related management systems. This is a great opportunity for you to gain experience in a variety of different market areas and expand and deepen your knowledge across multiple industries.
Responsibilities:- Use your experience in compliance to product regulations and quality standards (ISO 9001:2015, ISO 13485:2016, FDA QMSR 21 CFR 820) to provide a strategic advantage to client projects while expanding our knowledge and experience of European, US and Asian regulations (for both medical and non-medical applications).
- Take initiative in identifying and monitoring key changes in relevant international regulations, guidance and standards, and interpret and communicate what they mean for both the QA team and the wider business.
- Lead communications on quality and regulatory updates and run internal improvement initiatives, owning meaningful contributions to CC's global systems as a quality and regulatory technical lead.
- Support the fulfilment of external audit requirements alongside colleagues in QA and the wider business.
- Demonstrate and develop your leadership and project management skills to facilitate the work done by client project teams.
- Apply excellent attention to detail, quality assurance expertise and a collaborative approach to process improvements and the maintenance of QMS documentation.
- Find pragmatic but robust solutions in problem-solving under tough commercial, technical, time and regulatory constraints.
- Balance freedom to innovate with rigour in the design process by applying your knowledge and experience of quality management appropriately to the individual project situation.
- Be resourceful in your approach to contribute to projects with a widely varying breadth of disciplines, scale, complexity and requirements.
- Is a clear thinker, who can work independently, flexibly and inventively to facilitate others and show leadership in managing and undertaking activities.
- Is a proactive communicator and has the ability to develop relationships across a range of stakeholders, takes ownership of initiatives, delivers results, and strives for continual improvement.
- Can demonstrate a track record of developing and executing regulatory strategies that align with business needs and deliverables.
- Has the skill and experience to interpret regulatory and standard requirements to clarify the downstream implications for our processes.
- Knowledge of medical device compliance requirements.
Regulatory Affairs Specialist in Cambridge employer: Cambridge Consultants
At Cambridge Consultants, we pride ourselves on being an excellent employer that fosters a culture of innovation and collaboration. Our Regulatory Affairs Specialist role offers the unique opportunity to work at the forefront of breakthrough innovation while contributing to a diverse range of projects across medical and non-medical disciplines. With a strong emphasis on employee growth, we provide comprehensive training and development opportunities, ensuring our team members are equipped to excel in their careers within a supportive and dynamic environment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Cambridge
✨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 brushing up on your knowledge of ISO standards and FDA regulations. We recommend creating a cheat sheet of key points to discuss how your experience aligns with the role.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Be ready to share examples of how you've navigated complex regulatory challenges in the past. This will demonstrate your ability to balance innovation with compliance.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our team.
We think you need these skills to ace Regulatory Affairs Specialist in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with compliance, quality standards, and any relevant regulations like ISO 9001:2015 or FDA QMSR. We want to see how your background aligns with our needs!
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 you can contribute to our innovative projects. Be sure to mention specific experiences that demonstrate your leadership and problem-solving skills.
Showcase Your Communication Skills:As a Regulatory Affairs Specialist, you'll need to communicate effectively with various stakeholders. In your application, highlight instances where you've successfully led communications or collaborated with teams. We love seeing proactive communicators!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team at Cambridge Consultants!
How to prepare for a job interview at Cambridge Consultants
✨Know Your Regulations
Make sure you brush up on the key regulations and standards mentioned in the job description, like ISO 9001:2015 and FDA QMSR 21 CFR 820. Being able to discuss these confidently will show that you’re not just familiar with them but can also apply them strategically in your role.
✨Showcase Your Communication Skills
As a Regulatory Affairs Specialist, you'll need to communicate complex regulatory updates clearly. Prepare examples of how you've successfully communicated with stakeholders in the past, and be ready to demonstrate your proactive communication style during the interview.
✨Demonstrate Problem-Solving Abilities
Think of specific instances where you’ve found pragmatic solutions under pressure. Be prepared to discuss how you balanced innovation with regulatory compliance, as this is crucial for the role. Highlight your resourcefulness and ability to adapt to varying project requirements.
✨Emphasise Leadership and Collaboration
This role requires strong leadership and teamwork skills. Prepare to share experiences where you led initiatives or collaborated effectively with multidisciplinary teams. Show how you can facilitate others' work while driving quality and regulatory improvements.
