At a Glance
- Tasks: Manage regulatory documentation for medical devices and ensure compliance throughout their lifecycle.
- Company: Dynamic medical device manufacturer with a supportive SME culture.
- Benefits: Flexible 4½-day work week, hybrid options, and ongoing training opportunities.
- Other info: Collaborative environment with direct access to senior management and career growth potential.
- Why this job: Make a real impact in healthcare by ensuring product compliance and quality.
- Qualifications: Experience in regulatory affairs and technical writing within the medical device industry.
The predicted salary is between 40000 - 50000 £ per year.
Medical Device Regulatory Specialist
Hertfordshire – 37‑Hour Week, 4½‑Day Week, Hybrid Working Available, Permanent Opportunity
About the Role
As Regulatory Affairs Specialist / Technical Writer, you will take ownership of regulatory documentation for Class I and Class IIa medical devices, ensuring products remain compliant throughout their lifecycle. This is a varied role combining regulatory affairs, technical writing, quality support, and continuous improvement, making it ideal for someone who enjoys working across multiple disciplines within a collaborative SME environment.
What You Will Be Doing
- Maintain medical device registrations across the UK and EU
- Review, maintain, and update Technical Files for existing and new medical devices
- Prepare and maintain technical documentation to support regulatory compliance
- Review and update Instructions for Use (IFUs), technical reports, and regulatory documentation
- Prepare validation documents, gap analyses, technical justifications, and briefing papers
- Support UKCA, CE, MDD, and MDR compliance activities
- Monitor changes to regulatory legislation and implement updates where required
- Support external audits and provide regulatory input
- Produce Post Marketing Surveillance (PMS), PSUR, CEP, and CER documentation
- Liaise with customers and regulatory bodies regarding product compliance
- Maintain organised regulatory and quality records
- Deputise for the Quality Manager or Quality Engineer when required
What We're Looking For
- Previous Regulatory Affairs experience within the medical device industry
- Strong knowledge of ISO 13485, UKCA, CE MDD, and MDR regulations
- Experience preparing and maintaining Technical Files
- Technical writing experience within a regulated environment
- Experience working within an ISO‑regulated Quality Management System
- Excellent written communication and document control skills
- Strong analytical and problem‑solving abilities
- High attention to detail and excellent organisational skills
- Ability to work independently and manage multiple priorities
Desirable
- Internal Auditor qualification (ISO 9001 or ISO 13485)
- Engineering or manufacturing background
- Experience working within an SME environment
Benefits
- 37‑hour working week over 4½ days
- Hybrid working available
- Early finish on Fridays
- Opportunity to join a growing medical device manufacturer
- Supportive SME environment with direct access to senior management
- Ongoing training and professional development
- Opportunity to influence regulatory and quality improvements
Regulatory Affairs Specialist Quality Engineer in Hertford employer: Lawrence Dean Recruitment Ltd
Join a dynamic and supportive SME in Hertfordshire as a Regulatory Affairs Specialist, where you will enjoy a 37-hour work week spread over just 4½ days, allowing for a great work-life balance. With hybrid working options and direct access to senior management, this role offers excellent opportunities for professional growth and the chance to make a meaningful impact on regulatory and quality improvements within the medical device sector.
Contact Details:
Lawrence Dean Recruitment Ltd Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist Quality Engineer in Hertford
✨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 Lawrence Dean Recruitment Ltd looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Specialist Quality Engineer in Hertford
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 Lawrence Dean Recruitment Ltd. 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 Lawrence Dean Recruitment Ltd
✨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 Lawrence Dean Recruitment Ltd’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
