Medical Device Development - Consultant

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 multidisciplinary 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 crossfunctional expertise.
• Lead endtoend 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 AIdriven 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 crossfunctional 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 problemsolving skills and the ability to drive technical decisionmaking in a highly regulated environment.
• Ability to manage multiple concurrent projects ensuring alignment with business and regulatory needs.

We know the skillgap and somewhat need to tick every box can get in the way of meeting brilliant candidates so please dont hesitate to apply wed love to hear from you.

Apply today by completing our online application

Additional Information :

Life At PA encompasses our peoples experience at PA. Its 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 wellbeing 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 charitybased initiatives
• Annual performancebased 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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