Introduction:
Based in Gembloux, Intressa Vascular is a clinical-stage company developing an innovative medical implant to address life-threatening cardiovascular conditions such as aortic dissection.
Our mission is to help physicians address the devastating effect of aortic dissection by providing next-generation endovascular treatment.
To strengthen our team, we are looking for a Regulatory Specialist.
Job Purpose
Reporting to the Chief Strategy and Customer Officer, the Regulatory Specialist is responsible for ensuring that the company's products, processes or services comply with the laws, regulations and standards in force in the medical devices sector.
He/she plays a crucial role in maintaining compliance with local, national and international regulatory requirements, while facilitating the registration and marketing of new products or services. The role relies on transversal interactions and close collaboration with the design & development, clinical, operations, production and quality teams.
Duties and Responsibilities
He/she is responsible, in a proactive and objective-driven manner to:
- Contribute to the implementation of regulatory strategies as defined with management and internal development teams and external experts to meet company objectives and regulatory standards.
- Coordinate, write, establish and/or maintain up-to-date relevant technical and clinical documentation, including but not limited to Investigator Brochures, Technical Files, Product Risk Analysis and Risk Management Documentation, Clinical Evaluation Plan and Report, IFU.
- Coordinate interactions with regulatory bodies (i.e., Notified Body, Competent Authorities), and/or prepare documentation (e.g., change notifications, responses, safety reporting, etc.) for clinical study filings and pre-market approval applications in compliance with local requirements, company strategy and processes.
- Ensure Regulatory Watch is kept up-to-date and identify impact of new standards and regulatory changes to enable actions plans by the relevant internal teams.
Profile
- Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Biomedical Science, Civil Engineering or a related field.
- A certification in regulatory affairs is a plus.
- 5 years of experience in regulatory affairs for medical devices (preferably Class III).
- Strong knowledge of European Medical Device Regulation 2017/745; prior experience with US-FDA regulations is an asset.
- Experience in preparing and submitting regulatory dossiers (CE Marking, FDA, Technical File).
- Knowledge of ISO 13485 (Quality Management System)
- Ability to collaborate with Notified Bodies and regulatory authorities
- Ability to manage multiple priorities
- Strong project management and cross-functional coordination skills
- Excellent communication skills (written and verbally) and problem-solving abilities
- Attention to detail and ability to work in a regulated environment
Our offer
- A challenging and diversified position within a high-potential innovative medical device company.
- Working in a human-sized, collaborative, and respectful environment.
- An attractive compensation package in line with the position responsibilities and your experience.
- Available as employee or consultant role, depending on the candidate’s preference and qualifications.