At a Glance
- Tasks: Support innovative projects by ensuring compliance with global regulatory standards.
- Company: Dynamic tech and product development organisation in Cambridge.
- Benefits: Opportunity to work on breakthrough technologies and enhance your regulatory knowledge.
- Other info: Fast-paced environment with strong career growth potential.
- Why this job: Join a collaborative team shaping the future of medical devices and technology.
- Qualifications: Relevant degree and experience in regulatory affairs within the medical devices sector.
A growing technology and product development organisation in Cambridge is looking to appoint a Regulatory Affairs Specialist to support a wide range of innovative projects. This role sits within a team that works closely with engineers, scientists and designers, helping them bring complex ideas to life while ensuring that every development pathway aligns with global regulatory expectations. The work is varied, fast‐moving and highly collaborative, giving you the chance to contribute to breakthrough technologies across both medical and non‐medical sectors.You will be joining a quality and regulatory function that plays a central role in maintaining and improving the company's management systems. Rather than simply reviewing documents, this team is embedded in project activity, offering practical guidance that shapes product development from the earliest stages. In this position, you will provide regulatory support across the business, working with multidisciplinary teams and assisting senior members of the QA/RA group with the ongoing operation of the quality management system. The role offers exposure to a wide range of market areas, giving you the opportunity to broaden your regulatory knowledge and deepen your experience across multiple industries. You will be expected to apply your understanding of standards such as ISO 9001, ISO 13485 and FDA 21 CFR 820, helping teams navigate compliance requirements while still enabling innovation.A key part of your work will involve monitoring changes in international regulations and standards, interpreting what they mean for the organisation, and communicating updates to colleagues. You will contribute to internal improvement initiatives, support external audit activities, and help ensure that quality and regulatory processes remain robust, efficient and aligned with business needs. This role requires someone who can balance the freedom needed for creative problem‐solving with the discipline required for regulated product development, finding pragmatic solutions that work in real‐world commercial environments.Strong communication skills are essential, as you will be building relationships across a wide range of stakeholders and taking ownership of initiatives that improve the way the business operates. You should be able to demonstrate experience in developing or contributing to regulatory strategies, interpreting regulatory requirements, and understanding the implications for downstream processes. Knowledge of medical device compliance will be particularly valuable.It is expected that you will hold a relevant degree that has supported your move into a Regulatory Affairs position within the medical devices sector. It will also be important that you have contributed to a medical device that has progressed from early development through to commercial release, giving you a clear understanding of the full lifecycle and the regulatory considerations at each stage.If you have regulatory affairs experience and are looking for a challenging and rewarding role within a growing organisation, then apply now. I expect strong interest in this position, and the company is looking to move quickly, so I would recommend submitting your application immediately or risk missing out.For more information, please feel free to call Andrew Welsh, Director of Medical Devices, Biotech and DeepTech recruitment at Newton Colmore, on +44 121 268 2240, or make an application and one of our team will be in touch.
Manufacturing Specialist Quality (m/w) in Cambridge employer: Newton Colmore Consulting
Join a dynamic mechanical engineering services company that prioritises employee growth and development, offering clear progression pathways and a supportive work culture. With a focus on building long-term relationships and delivering exceptional service, you'll thrive in an environment that values your expertise and encourages innovation. Located centrally in Hampshire, this role provides the unique advantage of engaging with diverse industrial sectors across the South Coast, ensuring your contributions have a meaningful impact on the business's success.
StudySmarter Expert Advice🤫
We think this is how you could land Manufacturing Specialist Quality (m/w) in Cambridge
✨Join Local Manufacturing Groups
Getting involved in local manufacturing groups or associations can seriously boost your visibility. These groups often have insider info on job openings and networking events, plus they help you connect with like-minded folks in the industry. Check out what's happening in your area!
✨Show Off Your Skills in Practical Spaces
Consider participating in workshops or open days at manufacturing companies. It's a great way to show off your hands-on skills in a real-world environment and can sometimes lead to job offers right on the spot. Keep an eye on announcements from local manufacturers for these opportunities!
✨Leverage the Power of Internships
While you're looking for full-time positions, don't underestimate the power of internships! Even if you don't see a direct role, securing an internship at a company can open doors to future jobs. Many manufacturing firms prefer to hire from their intern pool, so it's definitely worth considering.
✨Apply Directly Through Company Websites
When you find a role at a company you love, like Newton Colmore Consulting, apply directly on their website. This way, you’re more likely to be noticed by the hiring team. Plus, showing that you took the time to seek out their application process highlights your genuine interest in the firm!
We think you need these skills to ace Manufacturing Specialist Quality (m/w) in Cambridge
Some tips for your application 🫡
Showcase Your Technical Skills:In the manufacturing-production sector, it's crucial to highlight your technical skills and experience. Make sure your CV features any relevant qualifications, such as certifications in machinery operation or production management, and don’t forget about any specific systems or software you’re familiar with. This can really set you apart!
Emphasise Teamwork and Communication:Working in manufacturing often means being part of a larger team. Highlight your experience in collaborative projects or environments where communication was key. Maybe you have experience with lean manufacturing principles? Talk about how you worked with your team to improve productivity and maintain quality.
Tailor Your Cover Letter to the Company:Don’t just recycle an old cover letter! Take the time to tailor your cover letter to Newton Colmore Consulting specifically. Mention what excites you about their production processes or products, and how your previous experiences can contribute to their goals. We want to see your enthusiasm for the role!
Use Concrete Examples of Your Achievements:When detailing your work experience, include measurable achievements that can demonstrate your impact. Whether it’s improving efficiency by a certain percentage or successfully leading a project, these specifics can make a huge difference. Numbers speak volumes in the manufacturing world!
How to prepare for a job interview at Newton Colmore Consulting
✨Know Your Manufacturing Processes
Before you walk into the interview with Newton Colmore Consulting, brush up on the specific manufacturing processes relevant to the role. Understanding lean manufacturing principles or quality control techniques could give you a solid edge to discuss how you’d fit into their operations.
✨Technical Questions Are Key
Be prepared for technical questions around machinery, production scheduling, or materials handling. Make sure you can confidently explain how you've dealt with these in past experiences or internships. Knowing industry-specific software could also be a big plus!
✨Showcase Your Problem-Solving Skills
Manufacturing environments often focus on continuous improvement. Be ready to discuss specific instances where you’ve solved a production issue or implemented a process improvement. It’s all about demonstrating your analytical thinking and hands-on approach.
✨Align Your Values with Quality and Safety
In a full-time role, companies like Newton Colmore Consulting value commitment to quality and safety. Be prepared to discuss how you prioritise these factors in your work. It’s about showing that you’re not just looking for a job, but that you genuinely care about contributing positively to their production environment.
