Medical Device Regulatory and Quality Consultant

Astro Studios, Inc.; Melbourn; Hybrid; GBP 50,000 - 70,000; Full time

Benefits offered by this job

Private healthcare

25 days annual leave

Generous pension scheme

Performance-based bonus

Share ownership

Tax-efficient benefits

Job summary

Astro Studios, Inc. is looking for a Medical Device Regulatory and Quality Consultant to join our dynamic Healthcare & Life Sciences consulting team in Melbourn, UK. This role involves providing regulatory and quality compliance expertise for medical devices and combination products. Candidates should have at least five years of experience in the MedTech field, a technical background, and a strong understanding of regulations. Benefits include private healthcare, generous leave, and a pension scheme.

Qualifications

• At least five years' experience in MedTech, pharmaceuticals, or life sciences.
• Demonstrated prior direct experience in design, development, or testing of medical devices.
• Ability to manage multiple concurrent projects.

Responsibilities

• Provide expertise on global regulatory requirements for medical devices.
• Guide processes for AI-driven medical device development.
• Develop and optimise clients’ Quality Management Systems.

Skills

Regulatory frameworks expertise

Problem-solving skills

Cross-functional collaboration

Education

Technical background in Engineering or Applied Science

Tools

ISO 13485

IEC 62304

GAMP

Job description

Medical Device Regulatory and Quality Consultant

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 – 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.

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. #LI-NF1