Medical Device Regulatory and Quality Consultant

Medical Device Regulatory and Quality Consultant

Full-Time 60000 - 80000 € / year (est.) No home office possible
PA Consulting

At a Glance

  • Tasks: Consult on medical device quality and regulatory processes while managing your own schedule.
  • Company: Dynamic healthcare firm focused on innovation and diversity.
  • Benefits: Health perks, generous leave, pension scheme, and performance bonuses.
  • Other info: Join a diverse team committed to community initiatives and personal growth.
  • Why this job: Make a real impact in the MedTech industry with your expertise.
  • Qualifications: Experience in medical devices and strong problem-solving skills 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.

The ideal candidate will have:

  • 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.

Benefits include 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, a generous company pension scheme, and the opportunity to get involved with community and charity‑based initiatives. There is also an annual performance‑based bonus, PA share ownership, and tax‑efficient benefits (cycle to work, give as you earn).

We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, or by any other range of human difference brought about by identity and experience. We are on a journey towards ensuring our workforce is diverse at all levels and that our firm is representative of the world around us. We welcome applications from underrepresented groups.

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: PA Consulting

Join a forward-thinking healthcare company that prioritises work/life balance and offers the autonomy to manage your own schedule. With a strong commitment to employee development, generous benefits including private healthcare, a robust pension scheme, and opportunities for community engagement, we foster a supportive and inclusive work culture. Our focus on diversity ensures that every voice is valued, making this an excellent place for professionals in the medical device sector to thrive.

PA Consulting

Contact Detail:

PA Consulting 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, join relevant online forums, and don’t be shy about reaching out on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!

Show Off Your Expertise

When you get the chance to chat with potential employers, make sure to highlight your experience with regulatory frameworks and your problem-solving skills. We want to see how you can bring your technical background to the table and tackle real-world challenges.

Prepare for the Interview

Do your homework on the company and its products before the interview. We recommend preparing some questions that show your interest in their work and how you can contribute. This will help you stand out as a candidate who’s genuinely invested in the role.

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 seeing candidates who take the initiative to engage directly with us.

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

Some tips for your application 🫡

Tailor Your CV:Make sure your CV highlights 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 your relevant skills 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 expertise can contribute to our team. Keep it engaging and personal – we love to see your personality come through.

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 share those stories!

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 the role. Plus, it’s super easy – just follow the prompts and you’ll be set!

How to prepare for a job interview at PA Consulting

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’re not just familiar with the theory but can apply it practically.

Showcase Your Technical Background

Prepare to talk about your technical experience 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 expertise.

Demonstrate Cross-Functional Collaboration

Think of examples where you’ve worked with engineering, quality, and regulatory teams. Be ready to explain how you contributed insights from your previous roles to drive decisions, as this is crucial for success in a regulated environment.

Problem-Solving Mindset

Be prepared to discuss challenges you've faced in past projects and how you resolved them. This will showcase your troubleshooting skills and ability to manage multiple projects effectively, which is essential for the role.