Senior Medical Device Quality & Regulatory Consultant
3 days ago
Châtillon
Are you ready to join a global leader in the exciting and dynamic fields of pharmaceuticals and medical devices? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees across Europe, Asia and the Americas. Due to our continuous growth, we are currently looking for a Senior Medical Device Quality & Regulatory Consultant to support a critical remediation project based in Chatillon, France. You will be responsible for • Leading and executing medical device quality system remediation activities, ensuring compliance with FDA regulations including 21 CFR Part 820, 21 CFR Part 4, and applicable FDA quality system requirements, • Collaborating with cross-functional teams including Quality Assurance, Engineering, Operations, Manufacturing, and Regulatory Affairs to ensure successful remediation execution, • Assessing current-state medical device quality system elements at the CMO and DBV facilities and identifying compliance gaps against FDA expectations, • Reviewing findings from mock prior approval inspections related to medical device components and supporting remediation activities, • Evaluating design controls, risk management activities, validation practices, device master records (DMR), and device history records (DHR), • Developing and executing remediation plans aligned with company compliance objectives and September 1st project timelines, • Supporting the implementation and integration of medical device quality system elements into existing pharmaceutical quality systems, • Conducting risk assessments for medical device processes and identifying practical mitigation strategies, • Overseeing remediation documentation including SOPs, work instructions, remediation plans, validation documentation, and compliance reports, • Supporting complaint handling and Medical Device Reporting (MDR) process assessments, • Providing guidance on FDA medical device regulatory expectations, including design controls and risk management principles under ISO 14971, • Training and mentoring CMO personnel and project stakeholders on FDA medical device quality system requirements and compliance practices, • Participating in SWAT team meetings, remediation workshops, and cross-functional war room discussions About you • Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, or a related field, • Minimum 8–10 years of experience in medical device quality and regulatory compliance, • Strong knowledge of FDA medical device regulations including 21 CFR Part 820 and design controls under 21 CFR 820.30, • Proven experience supporting FDA remediation projects for medical device manufacturers, • Hands-on experience implementing or remediating medical device quality systems, • Experience working within pharmaceutical, biologic, or combination product environments preferred, • Strong understanding of risk management principles including ISO 14971, • Comprehensive knowledge of Device Master Records (DMR) and Device History Records (DHR), • Experience with FDA inspections, Form 483 responses, and warning letter remediation activities, • Knowledge of complaint handling, Medical Device Reporting (MDR), and traceability requirements, • Excellent analytical, problem-solving, and technical writing skills, • Strong communication and collaboration skills, particularly within consulting or remediation environments, • Fluent English required, • French language proficiency highly preferred, • Ability to work onsite in Chatillon, France with significant facility presence required, • Willingness to work in a fast-paced remediation environment with occasional coordination across US and European teams Next Steps Upon receiving your application, if a match is found, the Recruiting Department will contact you for an initial HR interview. If the outcome is positive, a technical interview with the Hiring Manager and SWAT leadership team will be arranged. Following a successful interview process, the recruiter will contact you to discuss the next steps and contractual arrangements. If the outcome is negative, we will inform you accordingly and close the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a stimulating, multicultural company that values collaboration, quality, and innovation. PQE Group offers the opportunity to work on high-impact international remediation projects, develop your expertise, and collaborate with experienced professionals from across the world. If you are looking for a rewarding and exciting consulting opportunity in Chatillon, France, PQE Group is the perfect place for you. Apply now and take the first step toward an extraordinary future with us.
