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For Companies At a Glance
- Tasks: Lead regulatory compliance for medical devices and develop quality management systems.
- Company: Join Tellspec, a tech-driven company improving lives through innovative healthcare solutions.
- Benefits: Enjoy remote/hybrid work options, competitive pay, and opportunities for professional growth.
- Why this job: Make a real impact on healthcare for premature infants in a dynamic, compliance-focused environment.
- Qualifications: 4+ years in medical device regulatory affairs with strong UK MHRA knowledge required.
- Other info: Must be a UK resident; fluency in English is essential.
The predicted salary is between 36000 - 60000 £ per year.
Location: United Kingdom (Remote/Hybrid options if applicable)
About the Role
Preemie Analytics (www.preemiesensor.com) is seeking a highly skilled Regulatory Affairs Manager to lead the development, implementation, and maintenance of our Quality Management System (QMS) in compliance with UK Medical Device Regulations (UK IVD), ISO 13485, and other applicable standards. This role will serve as the primary regulatory contact for the MHRA, manage UKCA/CE marking submissions, and ensure adherence to post-market surveillance (PMS) requirements.
The ideal candidate will have strong expertise in UK/EU medical device regulations, hands-on experience with MHRA submissions, and a proven track record in QMS implementation for IVDs or medical devices.
Responsibilities
- Regulatory Affairs & Compliance
- Serve as the primary UK regulatory contact, managing communications with the MHRA and other relevant bodies.
- Prepare, submit, and maintain UK medical device registrations (UKCA), technical documentation, and EU IVDR compliance.
- Ensure compliance with post-market surveillance (PMS), vigilance reporting, and incident management.
- Monitor evolving UK MDR/IVDR regulations and implement necessary updates to maintain compliance.
- Quality Management System (QMS) Development
- Develop, implement, and maintain a robust QMS aligned with UK MDR, ISO 13485, and ISO 14971 (risk management).
- Conduct internal audits, manage CAPA (Corrective and Preventive Actions), and drive continuous improvement.
- Oversee document control, including SOPs, work instructions, and quality records.
- Quality Control & Compliance Oversight
- Manage incoming, in-process, and final product inspections to ensure compliance with specifications.
- Lead non-conformance investigations, root cause analysis (RCA), and risk assessments.
- Support supplier quality audits and vendor management.
- Cross-Functional Collaboration
- Provide regulatory guidance for new product development and design changes.
- Support international regulatory strategies (e.g., EU MDR, FDA) as needed.
Qualifications & Requirements
- Bachelor's or Master's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
- 4+ years of experience in medical device/IVD regulatory affairs, with a strong focus on UK MHRA requirements.
- In-depth knowledge of UK IVD Regulations.
- Hands-on experience with MHRA interactions, technical documentation, and regulatory filings.
- Strong QMS implementation, audit, and CAPA management skills.
- Excellent communication skills (written & verbal), with the ability to liaise with regulatory authorities.
- Regulatory Affairs Certification (RAC) is a plus.
Qualifications
- Must be a UK resident (applications from non-residents will not be considered).
- Fluent English (written & spoken) – 100%+ proficiency required.
- Regulatory expertise (UK MHRA/EU IVDR) – 4+ years minimum.
- Strong quality management & compliance mindset.
- Analytical thinking & attention to detail.
- Project management & cross-functional collaboration.
Why Join Us?
- Opportunity to shape and optimize regulatory strategies for innovative medical solutions to help premature infants.
- Work in a dynamic, compliance-driven environment with a growing team.
- Competitive compensation and professional growth opportunities.
Ready to apply? Submit your CV, proof of residence, and cover letter detailing your regulatory experience with UK MHRA & QMS.
Regulatory Affairs Manager (UK Medical Devices & IVD) employer: Tellspec
Contact Detail:
Tellspec Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager (UK Medical Devices & IVD)
✨Tip Number 1
Familiarise yourself with the latest UK Medical Device Regulations and IVD requirements. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with MHRA submissions. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your experience with QMS implementation and CAPA management. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Research Preemie Analytics and their products thoroughly. Understanding their mission and how your role as a Regulatory Affairs Manager can contribute to their goals will show your genuine interest in the position.
We think you need these skills to ace Regulatory Affairs Manager (UK Medical Devices & IVD)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, particularly with UK medical device regulations and MHRA submissions. Use specific examples that demonstrate your expertise in QMS implementation and compliance.
Craft a Compelling Cover Letter: In your cover letter, detail your relevant experience with UK IVD regulations and your role in managing communications with regulatory bodies. Emphasise your analytical skills and attention to detail, as these are crucial for the position.
Showcase Relevant Qualifications: Clearly list your qualifications, including any degrees in Engineering or Life Sciences, and mention your Regulatory Affairs Certification (RAC) if you have it. This will help establish your credibility in the field.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter for any errors. Ensure that your English is fluent and professional, as excellent communication skills are essential for this role.
How to prepare for a job interview at Tellspec
✨Know Your Regulations
Make sure you have a solid understanding of UK Medical Device Regulations and IVD requirements. Brush up on the latest updates from the MHRA, as being well-versed in these regulations will demonstrate your expertise and commitment to compliance.
✨Showcase Your QMS Experience
Prepare to discuss your hands-on experience with Quality Management Systems. Be ready to provide examples of how you've developed, implemented, or maintained a QMS in previous roles, particularly in relation to ISO 13485 and risk management.
✨Communicate Effectively
Since this role involves liaising with regulatory authorities, practice articulating your thoughts clearly and concisely. Highlight your communication skills during the interview by providing examples of how you've successfully managed communications with regulatory bodies in the past.
✨Demonstrate Cross-Functional Collaboration
Be prepared to discuss instances where you've worked collaboratively across different teams. This could include supporting product development or managing supplier quality audits. Show that you can work well with others to achieve regulatory compliance and quality goals.