Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device 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 QA/RA Strategist Consultant to join our team in Buffalo, NY. The mission of this role will be to contribute to PQE's growth in the US Market, and to support global clients with US regulatory and quality projects. 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. You will participate in the execution and coordination of compliance projects in Medical Device area, bring new expertise in and regulatory affairs for Medical Device, and provide guidance to the technical team. You will be responsible for
- Provide technical oversight of local and global MD compliance and regulatory projects
- Ensure effective Project Management during the activities execution including planning, monitoring and reporting
- Follow-up and coordinate with MD Management
- Support clients in projects related to US FDA Regulatory, Quality 21 CFR Part 820 and Clinical Study Design
- Support the Business Development teams to create and nurture new business relationships with Medical Device Companies in and out of the US
About you
- 3-7 years of previous experience in similar roles in the Medical Device field with broad spectrum of expertise in Regulatory Affairs of MD industry
- Knowledge of the MD local regulations
- Regulatory experience (510(k), PMA, De Novo, etc..)
- Understanding of Quality Management System requirements, risk management principles, regulatory requirements and, industry best practices:
- ISO 14971, Product Risk Management and Risk Analysis techniques
- Clinical Study Design and Execution
- Post market surveillance
- Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner.
- Highly self-motivated, self-directed
- Ability to work under pressure and flexibility to adapt to changing priorities
- Effective with written and verbal in English communications at all levels
- Experience in dealing with FDA and handling Q-submissions, and other submissions
Preferred Experience
- 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 with Software as a medical device or cybersecurity quality requirements
- Niche Medical Device RA expertise
- Experience in IVDs
- Experience in process validation
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.