Medical Device Regulatory and Quality Consultant
Medical Device Regulatory and Quality Consultant

Medical Device Regulatory and Quality Consultant

Full-Time 60000 - 80000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Consult on medical device quality and regulatory processes while managing your own schedule.
  • Company: Join PA Consulting, a leader in healthcare innovation with a focus on diversity.
  • Benefits: Enjoy health perks, 25 days leave, a generous pension scheme, and performance bonuses.
  • Other info: Be part of a diverse team that values unique perspectives and fosters growth.
  • Why this job: Make a real impact in MedTech while enjoying a flexible work-life balance.
  • Qualifications: Experience in medical devices, strong problem-solving skills, and a technical background 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 team. You will 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.

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 employer: Consultancy.uk

At PA Consulting, we pride ourselves on being an exceptional employer, offering a supportive and inclusive work culture that prioritises the well-being of our employees. Located in Melbourn, our team enjoys flexible working arrangements, extensive health benefits, and numerous opportunities for professional growth, all while contributing to meaningful projects in the healthcare sector. We celebrate diversity and encourage innovative thinking, making PA a truly rewarding place to advance your career in medical device regulation and quality.
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Contact Detail:

Consultancy.uk Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Medical Device Regulatory and Quality Consultant

✨Network Like a Pro

Get out there and connect with folks in the MedTech and regulatory space. Attend industry events, webinars, or even local meetups. You never know who might have the inside scoop on job openings or can put in a good word for you!

✨Show Off Your Expertise

When you get the chance to chat with potential employers, don’t hold back! Share your experiences and insights from your previous roles. This is your time to shine and demonstrate how your background aligns perfectly with their needs.

✨Tailor Your Approach

Every company is different, so make sure you tailor your conversations to reflect their values and culture. Research their projects and challenges, and come prepared with ideas on how you can contribute. It shows you’re genuinely interested!

✨Apply Through Our Website

Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love hearing from passionate candidates like you who are eager to make a difference in the healthcare sector.

We think you need these skills to ace Medical Device Regulatory and Quality Consultant

Regulatory Frameworks (FDA, EMA, MDR/IVDR)
ISO 13485
IEC 62304
ISO 14971
GAMP
21 CFR 4/820
Medical Device Design and Development
Problem-Solving Skills
Technical Decision-Making
Project Management
Cross-Functional Collaboration
Troubleshooting Expertise
Experience in MedTech, Pharmaceuticals, or Life Sciences
Engineering Background (Biomedical, Mechanical, Electrical, Software)
Ability to Manage Multiple Concurrent Projects

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to highlight your experience in medical devices and regulatory processes. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your skills can contribute to our team. Keep it engaging and personal – we love getting to know the real you.

Showcase Your Problem-Solving Skills: In your application, give examples of how you've tackled challenges in regulated environments. We’re looking for candidates who can demonstrate their troubleshooting expertise and decision-making abilities, so don’t hold back!

Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re keen on joining our team at StudySmarter!

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 in detail will show your expertise and understanding of the industry.

✨Showcase Your Technical Background

Prepare to talk about your technical background in engineering or applied sciences. Highlight specific projects where you contributed to the design or testing of medical devices, as this will demonstrate your hands-on experience.

✨Demonstrate Cross-Functional Collaboration

Be ready to share examples of how you've worked with different teams, such as engineering and quality assurance. This will illustrate your ability to collaborate effectively in a regulated environment, which is crucial for this role.

✨Problem-Solving Mindset

Think of specific challenges you've faced in previous roles and how you resolved them. Discussing your problem-solving skills will show that you can navigate the complexities of regulated product development.

Medical Device Regulatory and Quality Consultant
Consultancy.uk

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