At a Glance
- Tasks: Advise on regulatory and quality compliance for medical devices and combination products.
- Company: Join a leading consulting firm dedicated to innovation in healthcare.
- Benefits: Enjoy health perks, 25 days leave, and a generous pension scheme.
- Other info: Flexible working environment with opportunities for personal and professional growth.
- Why this job: Make a real impact in MedTech while working with diverse teams.
- Qualifications: Experience in medical device development and strong regulatory knowledge required.
The predicted salary is between 60000 - 80000 € per year.
We are seeking a highly skilled consultant with experience in medical device and/or combination product Quality and Regulatory processes to join our Healthcare & Life Sciences (HLS) consulting team. This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and quality requirements for medical devices, software as a medical device (SaMD), and/or combination products. The ideal candidate will have experience leading complex technical projects, integrating multidisciplinary expertise, and ensuring regulatory and quality compliance in innovative MedTech and pharmaceutical product developments.
Key Responsibilities
- Provide expertise on global regulatory requirements for medical devices and combination products ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
- Guide processes for hardware, software, and AI-driven medical device development to ensure compliance with applicable regulatory standards and guidance, including ISO 13485, ISO 14971, IEC 62304, and related standards and guidance for AI-driven medical technologies.
- Advise cross-functional teams of designers, mechanical, electrical, software and usability engineers on requirements and best practices for regulatory and quality compliance.
- Ensure requirements traceability from user needs through design, development, verification, and validation.
- Lead risk management activities in accordance with ISO 14971, ensuring safety and efficacy through robust design and process controls.
- Develop and optimise clients’ Quality Management Systems (QMS) to streamline compliance and lifecycle management.
Stakeholder & Client Engagement
- Work closely with clients’ R&D teams, business stakeholders, and notified bodies to align project goals with industry requirements.
- Facilitate cross-functional collaboration, ensuring smooth integration between engineering, quality, and regulatory disciplines.
- Translate complex technical and regulatory requirements into actionable development strategies for medical technologies.
Flexible working - We are guided by our client work and needs; however, you have autonomy to manage your time and diary to suit your work/life balance.
Qualifications
- A technical background in Engineering (systems, biomedical, mechanical, electrical, software, or related field) or Applied Science (physics, chemistry, biology, materials science, etc.).
- Demonstrated prior direct experience in the design, development, or testing of medical devices and/or combination products.
- At least five years' experience in MedTech, pharmaceuticals, or life sciences, with a strong track record in regulated product development.
- Deep expertise in regulatory frameworks (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971, GAMP, 21 CFR 4/ 820).
- Proven ability to work cross-functionally with engineering, quality, and regulatory teams, contributing practical insights from previous technical roles.
- Strong problem-solving skills, troubleshooting expertise and the ability to drive technical decision-making in a highly regulated environment ensuring alignment with business and regulatory needs.
- Ability to manage multiple concurrent projects.
We know the skill-gap and the ‘need to tick every box’ can get in the way of meeting brilliant candidates, so please don’t hesitate to apply – we’d love to hear from you.
Additional information
Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples’ working lives by giving them access to unique people and growth opportunities and purpose led meaningful work. We believe diversity fuels ingenuity. Diversity of thought brings exciting perspectives; diversity of experience brings a wealth of knowledge, and diversity of skills brings the tools we need. When we bring people together with diverse backgrounds, identities, and minds, embracing that difference through an inclusive culture where our people thrive; we unleash the power of diversity – bringing ingenuity to life.
Find out more about Life at PA here.
We Are Dedicated To Supporting The Physical, Emotional, Social And Financial Well-being Of Our People. Check Out Some Of Our Extensive Benefits:
- Health and lifestyle perks accompanying private healthcare for you and your family.
- 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days.
- Generous company pension scheme.
- Opportunity to get involved with community and charity-based initiatives.
- Annual performance-based bonus.
- PA share ownership.
- Tax efficient benefits (cycle to work, give as you earn).
Adjustments or accommodations - Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us.
Medical Device Regulatory and Quality Consultant in Melbourn employer: Consultancy.uk
At PA Consulting, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the Healthcare & Life Sciences sector. Our Melbourn location provides a supportive environment with flexible working arrangements, extensive health and lifestyle benefits, and numerous opportunities for professional growth, ensuring that our employees thrive both personally and professionally while contributing to meaningful projects in the MedTech field.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Device Regulatory and Quality Consultant in Melbourn
✨Tip Number 1
Network like a pro! Reach out to your connections in the MedTech and life sciences sectors. Attend industry events, webinars, or even local meetups. You never know who might have the inside scoop on job openings or can refer you directly to hiring managers.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory frameworks and quality compliance. Be ready to discuss how your experience aligns with the specific needs of the role. Practise answering common interview questions related to medical device development and compliance.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your past projects, especially those involving regulatory and quality compliance. This will give potential employers a tangible sense of your skills and how you can contribute to their team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at StudySmarter. We can’t wait to hear from you!
We think you need these skills to ace Medical Device Regulatory and Quality Consultant in Melbourn
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the job description. Highlight your expertise in regulatory and quality compliance for medical devices, as this is key for us.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're the perfect fit for this role. Share your passion for MedTech and how your background aligns with our needs in regulatory processes and compliance.
Showcase Your Projects:If you've led complex technical projects, don’t hold back! Describe these experiences in your application to demonstrate your ability to manage multiple concurrent projects effectively.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Consultancy.uk
✨Know Your Regulations
Make sure you brush up on the key regulatory frameworks like FDA, EMA, and ISO standards relevant to medical devices. Being able to discuss these confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Technical Expertise
Prepare to discuss your technical background in engineering or applied sciences. Highlight specific projects where you led complex technical initiatives, especially those involving multidisciplinary teams. This will demonstrate your ability to integrate various expertise areas.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or quality compliance issues. Think of examples from your past experience where you successfully managed risk or ensured compliance, and be ready to explain your thought process.
✨Engage with Stakeholders
Be prepared to talk about your experience working with cross-functional teams and clients. Share examples of how you facilitated collaboration between engineering, quality, and regulatory disciplines, as this is crucial for the role.
