At a Glance
- Tasks: Drive IVDR transition, manage technical documentation, and support regulatory submissions.
- Company: Join SureScreen Diagnostics, a leader in bespoke diagnostic solutions for over 30 years.
- Benefits: Friendly environment, professional growth, and potential for contract extension or permanent role.
- Other info: Collaborative team culture with opportunities to connect and grow.
- Why this job: Make a real impact in the medical device industry while expanding your expertise.
- Qualifications: Degree in relevant field and 5 years of Regulatory Affairs experience required.
The predicted salary is between 40000 - 50000 £ per year.
SureScreen Diagnostics are an innovative and forward-thinking company creating bespoke diagnostic solutions, products and tailored services for organisations across the UK and Europe for over 30 years. Our mission is to provide the best quality diagnostic products that meet and exceed customers’ expectations at a fair price. We pride ourselves on having a diverse range of talented, hardworking and dynamic individuals within our team. We provide a friendly, challenging and rewarding environment that will help individuals expand their knowledge, build connections and grow professionally.
We are looking for a Regulatory Affairs Specialist to help support the transition to IVDR for our product portfolio. This is a fixed term contract of 12 months with a real possibility of extension or permanent position through this is not guaranteed.
Job Purpose: To drive the transition to IVDR across the product range, ensuring robust technical documentation, supporting regulatory submissions, and managing product lifecycle activities to maintain ongoing compliance and market access.
Key Accountabilities and Responsibilities:
- IVDR Compliance, Technical Documentation & NPD Support: Prepare, review, and maintain IVDR Technical Documentation and associated regulatory records. Support IVDR conformity assessment activities, including Notified Body submissions. Provide regulatory input into New Product Development (NPD), ensuring IVDR requirements are embedded from design through to launch and lifecycle management. Assess regulatory impact of product changes, including design, labelling, manufacturing, and supplier updates. Review and maintain Instructions for Use (IFUs), labelling, declarations of conformity, and regulatory claims.
- Regulatory Operations & Post-Market Activities: Support UDI implementation, EUDAMED registrations, and device data management. Contribute to Post-Market Surveillance (PMS), vigilance reporting, and Field Safety Corrective Actions (FSCAs).
- Audit, Regulatory Intelligence & Continuous Improvement: Support internal and external audits and regulatory inspections. Monitor changes in regulations and standards, assessing business impact. Contribute to improvements in regulatory processes and systems.
Key Relationships:
- Internal: Regulatory Affairs Manager, R&D Team, Sales, Marketing, Operations inc. production, Quality
- External: Regulatory authorities, Notified bodies
Qualifications, skills, and experience:
- Degree in Life Sciences, Biomedical Sciences, Regulatory Affairs, Pharmacy, Engineering, or a related discipline
- Minimum 5 years’ Regulatory Affairs experience within the medical device or IVD industry
- Strong knowledge of IVDR (EU 2017/746), ISO 13485, and regulatory compliance requirements
- Experience preparing and maintaining IVD Technical Documentation
- Experience supporting Notified Body audits, submissions, and regulatory projects
- Familiarity with UDI, EUDAMED, PMS, Vigilance, and risk management activities
- Strong organisational skills with the ability to manage multiple priorities and meet deadlines
- Excellent written and verbal communication skills
- Has good attention to detail
- Has a strong sense of urgency
- Is self-motivated
- Displays a positive can-do-it attitude
Regulatory Affairs Specialist (IVDR) – Fixed Term Contract in Derby employer: The SureScreen Group
As an Occupational Health & Workplace Screening Technician, you'll be part of a dynamic and supportive team dedicated to delivering high-quality services across various industries. Our company values employee growth, offering ongoing training and professional development, while providing the flexibility of a mobile role with a company vehicle for business travel. Join us for a rewarding career where your contributions are valued, and you can make a meaningful impact on workplace health and safety.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist (IVDR) – Fixed Term Contract in Derby
✨Dive into Industry Groups
Join compliance and risk management groups on platforms like LinkedIn and Facebook. These communities often share temp job postings and insights. You’d be surprised at how many temporary gigs float around through word of mouth!
✨Showcase Your Expertise
Consider creating content on compliance topics that get you noticed—think LinkedIn articles or even a blog. This not only shows off your knowledge but can grab the attention of companies like The SureScreen Group when they’re searching for someone to fill a temporary position.
✨Tap into Recruitment Agencies
Reach out to recruitment agencies that specialise in compliance and risk roles. They’re usually in touch with companies looking to fill temporary roles, which can save us a lot of time in our job search.
✨Go Local with Networking
Attend local compliance and risk seminars or workshops. Meeting professionals in our area can open up temp opportunities, and it’s a great way to make your face known in the industry—plus, you might even meet someone from The SureScreen Group!
We think you need these skills to ace Regulatory Affairs Specialist (IVDR) – Fixed Term Contract in Derby
Some tips for your application 🫡
Show Your Compliance Know-How:When you’re applying for a compliance-risk role like Regulatory Affairs Specialist (IVDR) – Fixed Term Contract, make sure to highlight your understanding of industry regulations and risk management principles. Mention any relevant coursework, certifications, or projects that showcase your expertise in these areas—it's what sets you apart!
Highlight Your Analytical Skills:In the compliance-risk field, strong analytical skills are essential. Talk about your experiences that required critical thinking and data analysis, whether in past roles, internships, or academic projects. Show us how you've identified risks and implemented solutions in the past.
Tailor Your CV for the Temporary Role:Since this is a temporary role, focus on your availability and flexibility in your CV. Highlight any previous short-term roles or projects that demonstrate your ability to adapt quickly and deliver results in a fast-paced environment. This helps employers see you as an easy fit in their team!
A Concise Cover Letter is Key:Keep your cover letter short and focused! Explain why you're interested in the compliance-risk area specifically for this temporary position at The SureScreen Group. Mention what you hope to learn and achieve, showing your enthusiasm and motivation to contribute positively during your time there.
How to prepare for a job interview at The SureScreen Group
✨Know Your Compliance Basics
Make sure you're clued up on the key compliance and risk regulations pertinent to the industry you're applying to. Understanding frameworks like GDPR or AML will not only impress but also show that you’re ready to hit the ground running in your temporary role at The SureScreen Group.
✨Prepare for Scenarios
Expect scenario-based questions that test your problem-solving skills. They might ask how you'd handle a specific compliance issue. Think through real situations you’ve encountered in past roles or study hypothetical cases to showcase your analytical skills and practical judgement during the interview.
✨Highlight Your Adaptability
Since this is a temporary position, emphasise your ability to adapt quickly to new environments and team dynamics. Share examples of how you’ve successfully adjusted to changes in past roles and how this flexibility can benefit The SureScreen Group in the short term.
✨Gather Your Technical Tools
Familiarise yourself with commonly used compliance tools or software, as they might come up in the interview. If you've used tools for risk assessments or compliance tracking, mention those and be ready to discuss how they can streamline processes at The SureScreen Group.
