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- Tasks: Lead the development of innovative medical devices and ensure regulatory compliance.
- Company: Join a diverse team dedicated to creating a positive human future through ingenuity.
- Benefits: Enjoy health perks, 25 days leave, a pension scheme, and community involvement opportunities.
- Why this job: Be part of groundbreaking projects in MedTech while collaborating with experts across disciplines.
- Qualifications: 5+ years in MedTech with strong project management and regulatory expertise required.
- Other info: We value diversity and encourage applications from all backgrounds.
The predicted salary is between 43200 - 72000 £ per year.
Company Description
About us
We believe in the power of ingenuity to build a positive human future.
As strategies, technologies, and innovation collide, we create opportunity from complexity.
Our diverse teams of experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results.
We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport.
Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.
PA. Bringing Ingenuity to Life.
Job Description
We are seeking a highly skilled consultant with experience in medical device development to join our Life Sciences consulting team. This role focuses on the development of medical devices, including 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 while driving innovation in MedTech and pharmaceutical product development.
Key Responsibilities:
Technical Leadership
- Act as a systems engineering leader, bringing together multi-disciplinary teams – design, mechanical, electrical, software, quality and regulatory – to develop complex medical and drug delivery devices.
- Define system architecture, ensuring alignment with safety, usability, and regulatory requirements (ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR 4/ 820).
- Oversee technical project management, ensuring clear requirements, risk management, and seamless integration of cross-functional expertise.
- Lead end-to-end product development, from user needs analysis and design to development, verification, validation, and regulatory approval.
Regulatory & Quality Compliance for Medical/ Drug Delivery Devices
- Provide expertise on global regulatory requirements for medical/ drug delivery devices, ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
- Lead risk management activities (ISO 14971), ensuring safety and efficacy through robust design and process controls.
- Guide processes for hardware, software, and AI-driven medical devices, including compliance with IEC 62304 (medical software lifecycle processes) and IEC 62366 (usability engineering for medical devices).
- Develop and optimise Quality Management Systems (QMS) to streamline compliance and lifecycle management.
Stakeholder & Client Engagement
- Work closely with clients, R&D teams, business stakeholders, and regulatory 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
- Engineering background (systems, biomedical, mechanical, electrical, software, or related field).
- At least five years\’ experience in MedTech, pharmaceuticals, or life sciences, with a strong track record in medical device development and technical project management.
- Deep expertise in regulatory frameworks (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971, GAMP, 21 CFR 4/ 820).
- Experience leading complex, multidisciplinary product development projects, integrating hardware, software, and regulatory expertise.
- Strong problem-solving skills and the ability to drive technical decision-making in a highly regulated environment.
- Ability to manage multiple concurrent projects, ensuring alignment with business and regulatory needs.
We know the skill-gap and ‘somewhat 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)
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 other 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.
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Medical Device Development - Consultant employer: PA Consulting
Contact Detail:
PA Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Development - Consultant
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks mentioned in the job description, such as ISO 13485 and FDA regulations. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Highlight any experience you have leading multidisciplinary teams in your previous roles. Be prepared to discuss specific projects where you successfully integrated different areas of expertise, as this is a key responsibility for the position.
✨Tip Number 3
Network with professionals in the MedTech and life sciences sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends, which can give you an edge in discussions during the interview process.
✨Tip Number 4
Prepare to discuss your problem-solving skills in detail. Think of examples where you navigated complex challenges in medical device development, as this will showcase your ability to drive technical decision-making in a highly regulated environment.
We think you need these skills to ace Medical Device Development - Consultant
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Medical Device Development Consultant position. Tailor your application to highlight relevant experience in medical device development and regulatory compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in leading complex technical projects and your expertise in regulatory frameworks such as FDA, EMA, and ISO standards. Use specific examples to demonstrate your problem-solving skills and ability to manage multidisciplinary teams.
Showcase Technical Leadership: Make sure to illustrate your technical leadership capabilities. Discuss how you've successfully integrated cross-functional expertise in previous roles and how you have driven innovation in MedTech or pharmaceutical product development.
Engage with the Company’s Values: Reflect on the company’s commitment to diversity and ingenuity in your application. Share how your unique background and experiences can contribute to their inclusive culture and innovative environment.
How to prepare for a job interview at PA Consulting
✨Showcase Your Technical Leadership
Be prepared to discuss your experience in leading multidisciplinary teams. Highlight specific projects where you acted as a systems engineering leader, focusing on how you integrated design, mechanical, electrical, and software expertise to develop medical devices.
✨Demonstrate Regulatory Knowledge
Familiarize yourself with global regulatory requirements relevant to medical devices. Be ready to explain how you've ensured compliance with standards like ISO 13485, IEC 62304, and FDA regulations in your previous roles.
✨Engage with Stakeholders
Prepare examples of how you've worked closely with clients and R&D teams to align project goals with industry requirements. Emphasize your ability to translate complex technical and regulatory requirements into actionable strategies.
✨Highlight Problem-Solving Skills
Expect questions that assess your problem-solving abilities in a regulated environment. Share specific instances where you successfully navigated challenges in medical device development, showcasing your critical thinking and decision-making skills.
