Regulatory Affair Advisor jobs

Job description

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:

Regulatory & Quality Compliance for Medical Devices and Combination Products

• 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

• 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.

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)

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.

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