Medical Device Regulatory and Quality Consultant Full-time 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, andtogether 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, andtransport. Our teams operate globally from offices across theUK, Ireland, US, Nordics, and Netherlands. PA. Bringing Ingenuity to Life. We are seeking a highly skilled consultant with experience in medical device and/or combination product Quality and Regulatory processes to join our Healthcare however, you 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. 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. 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 5additional 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 By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply Job Location #J-18808-Ljbffr
Remote MedTech Regulatory & Quality Consultant employer: PA Consulting
At PA Consulting, we pride ourselves on being an excellent employer that fosters a collaborative and innovative work culture. As a Data Architect, you will have the opportunity to lead transformative projects in a hybrid working environment, allowing for flexibility while engaging with clients and colleagues. We are committed to your professional growth, offering continuous learning opportunities and the chance to work on cutting-edge AI-driven data solutions that make a real impact.
