At a Glance
- Tasks: Lead compliance strategy and oversee regulatory affairs in a fast-growing diagnostics company.
- Company: Guilford Street Laboratories, an innovative UCL spin-out transforming disease management.
- Benefits: Competitive salary, contributory pension, life insurance, and optional private health insurance.
- Other info: Exciting opportunity for career growth in a collaborative and innovative environment.
- Why this job: Shape the future of medical diagnostics while building a dynamic compliance team.
- Qualifications: Degree in life sciences or related field, with 3+ years in compliance or regulatory affairs.
The predicted salary is between 42750 - 52250 £ per year.
Head of Compliance and Regulatory Affairs | Up to £60,000 | London | Permanent Are you experienced in quality management and regulatory affairs within medical diagnostics or life sciences?
Would you like to shape compliance strategy within a fast-growing UCL spin-out?
The role Guilford Street Laboratories is seeking a Head of Compliance and Regulatory Affairs to oversee company certifications, regulatory clearances and international standards.
You will develop and maintain our Quality Management System and Information Security Management System, manage regulatory submissions and prepare the business for audits and inspections.
As the company expands, you will also build and lead an effective compliance team.
The role is primarily based across our offices in Kings Cross and Guilford Street, London, with monthly travel to Liverpool.
Key responsibilities Maintain compliance with ISO 27001, ISO 9001, ISO 13485 and ISO 15189.
Manage UKCA, CE and FDA 510(k) regulatory submissions.
Oversee regulatory clearances for medical devices and services in the UK, EU and US.
Maintain QMS and ISMS documents, records and supporting evidence.
Conduct internal audits and manage corrective actions.
Deliver QMS and ISMS training, including staff inductions.
Approve and monitor vendors against company quality standards.
Manage post-market surveillance alongside sales and marketing.
Oversee specialist quality and regulatory consultants.
Build the compliance function as the business grows.
About our company Guilford Street Laboratories is a fast-growing spin-out from University College London.
We develop and deliver innovative products and services within proteomics diagnostics, with the potential to transform how diseases are identified and managed.
The
Benefits: Contributory Pension scheme
auto enrolment Life Insurance- auto enrolment Optional Private Health Insurance - after qualifying period The person You will need: A degree or equivalent qualification in life sciences, quality management or a related subject.
At least three years experience in compliance, QMS or regulatory affairs, ideally within proteomics, IVD or Sa MD.
An Internal Auditor qualification in ISO 13485, ISO 9001 or ISO 27001.
Knowledge of medical device regulations and regulatory approval processes.
Experience working with external stakeholders and consultants.
Strong organisational, record-keeping and communication skills.
Permanent right to work in the UK.
Further Lead Auditor training across relevant ISO standards and GCP would be welcomed.
Whats next?
If you are ready to take ownership of compliance and regulatory affairs within a growing diagnostics company, apply today.
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Head of Compliance and Regulatory Affairs in Slough employer: Ecruit
Join a dynamic team as an Air Conditioning Field Engineer, where your expertise will be valued and rewarded. With a strong focus on employee growth, we offer extensive training opportunities and a supportive work culture that encourages innovation and collaboration. Enjoy the benefits of a competitive salary, overtime pay, and a company van, all while working in the vibrant North West London area, known for its diverse community and thriving economy.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Compliance and Regulatory Affairs in Slough
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Ecruit looking for candidates who are engaged and informed.
We think you need these skills to ace Head of Compliance and Regulatory Affairs in Slough
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Ecruit. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Ecruit
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Ecruit’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
