Quality Assurance Regulatory Affairs Medtech Industry

Agap2 is a European engineering and operational consulting group founded
in 2005 and specialized in the industry. We work in the Life Science Energy
Infrastructure Transportation Chemicals sectors.

As a consultant you will have to support our clients
in the realization of their projects on site by bringing your expertise and
your skills.

You are agile and eager to adapt to different work
environments that will fuel your curiosity of seeing whats behind closed doors
of the biggest projects of our clients portfolio.

Tasks

We are looking for a dynamic professional to step into a pivotal role that includes responsibility in Design Control Quality Assurance (QA) and Regulatory Affairs (RA) for one of our clients.

KEY RESPONSIBILITIES

Oversee Project Excellence Quality Assurance and Design Control:

• Provide essential guidance on quality requirements to drive product development.
• Collaborate with R&D to develop and implement effective inspection and test methods.
• Manage the review and approval process for design & development documentation facilitating the creation of Design Traceability Matrix and Design History File.
• Lead risk management activities with a specific focus on Design and Process FMEA.
• Review and support manufacturing process documentation including process validation (V&V) protocols and reports.

Ensure Regulatory Affairs and Quality Management Mastery:

• Lead regulatory and quality efforts aligned with strategic imperatives.
• Establish and maintain a robust Quality Management System ensuring continuous compliance with ISO 13485 standards.
• Foster seamless collaboration with the internal clinical function.
• Develop plan and execute a successful regulatory submission strategy for product approval in the United States (FDA) and Europe (CE).

Requirements

• Masters degree in engineering (Biomedical Mechanical or Manufacturing) or any equivalent scientific discipline.
• Minimum of 10 years of professional experience in Quality Management systems and Regulatory Affairs for medical devices.
• Strong experience with international norms ISO 13485 and ISO 14971 and a good knowledge of GMP FDA regulations 21 CFR 820 and EU 2017/745. Possession of relevant certifications in this domain is a valuable advantage.
• Demonstrated oversight of audits and inspections with expertise in structured product development including Design Control and Process Validation.
• Strong communicator with strategic thinking proactive approach and proven skills in data analysis organization and problemsolving.
• Proficient in English.