Job Description

Medical Device Compliance Executive Consultant US Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Devices industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. Following a new opportunity, we are currently looking for a Medical Device Compliance Executive Consultant US based in Boston, USA . The mission of a Medical Device Compliance Executive Consultant will be to contribute to PQE growth in the US Market, support the Sales Team to understand the client's needs, translate them into tailored services, and guide their execution. The role is dedicated to the Medical Device industry and involves active coordination across teams, therefore it demands exceptional inter-personal skills as well as extensive knowledge of Medical Device requirements. Job roles and responsibilities: Act as a local SME supporting the sales team to understand Medical Device clients' needs. Support in writing new business proposals. Support the recruiting process to assess the MD technical expertise of new operational team members. Provide technical oversight of local MD compliance and regulatory projects. Tutorship of junior resources and coordination of MD local operations and projects execution. Provide input, coordination, and regulatory guidance to the local operational team. Ensure effective Project Management during the activities execution including planning, monitoring, and reporting. Grant projects governance with a focus on timelines and budget control. Follow-up and coordinate with Headquarter Management. Competencies and Skills Required: 5+ years of previous experience in similar roles in the Medical Device field with broad expertise in Quality Assurance/Regulatory Affairs of the MD industry. Knowledge of the MD international and local regulations. Understanding of Quality Management System requirements, risk management principles, regulatory requirements, and industry best practices. Technical skills in Medical Device industry processes. Experience in dealing with FDA. Strong analytical skills with the ability to organize work in a logical, thorough, and succinct manner. Detail-oriented and an active listener. Highly self-motivated and self-directed. Ability to work under pressure. Flexibility to adapt to changing priorities. Effective written and verbal communication in English at all levels. Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency. Work Location: Boston area/Florida Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome from the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us. Seniority Level Executive Employment Type Full-time Job Function Consulting, Quality Assurance, and Project Management Industries Business Consulting and Services, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing #J-18808-Ljbffr PQE Group

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