What are the responsibilities and job description for the Medical Device Compliance Executive Consultant US position at PQE Group?
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, to support the Sales Team to understand the client's needs, to translate them into tailored services, then to guide their execution.
The role is expressly dedicated to 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
The Executive Consultant is expected to take part in sales meeting as Medical Device SME, to provide persuasive introduction to PQE products and services, to understand customer needs, and work on technical object of new business proposals.
Then the Executive Consultant shall participate in the execution and coordination of compliance projects in Medical Device area, bring new expertise in quality management and regulatory affairs for Medical Device, provide guidance to the technical team.
The person will also contribute to enhance PQE services in Medical Device area and to develop the Medical Device Team.
The primary role and responsibilities of a MD Compliance Executive Consultant will include:
- Act as a local SME supporting to 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 local operational team
- Ensure effective Project Management during the activities execution including planning, monitoring and reporting
- Grant projects governance with focus on time lines 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 spectrum of expertise in Quality Assurance/ Regulatory Affairs of 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:
- ISO 13485, MDR 2017/745, 21 CFR part 820, …
- ISO 14971, Product Risk Management and Risk Analysis techniques
- V&V requirements
- Post market surveillance
- Technical skills in Medical Device industry processes
- Development/review of manufacturing processes maps and process FMEA, with critical points identification and mitigation
- Development of process validation protocols (IQ-OQ-PQ) and writing of summary reports
- 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, self-directed
- Ability to work under pressure
- Flexibility to adapt to changing priorities
- Effective with written and verbal in English communications 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 coming from Hiring Manager interview, 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.
