We are a biotechnology company focused on developing innovative genomic solutions for precision medicine in oncology. We are seeking a highly motivated REGULATORY AFFAIRS MANAGER to join us.
The job purpose is to lead and oversee all regulatory activities related to the development, approval, and commercialization of the company in vitro medical devices. The Regulatory Affairs Manager ensures implementation of Quality Management System, compliance with applicable regulations (such as IVDR, ISO 13485, and FDA guidance), manages regulatory submissions and audits, and contributes to the overall strategy to bring innovative products to market efficiently and compliantly.
RESPONSABILITIES
- Define and implement regulatory strategies for new and existing products.
- Ensure compliance with applicable regulations (IVDR, MDR, ISO 13485, FDA, etc.).
- Prepare and maintain regulatory documentation and technical files.
- Accountable for the implementation of the Quality Management System
- Acts as a Person Responsible for Regulatory Compliance
- Acts as a Vigilance Manager
- Lead communication with regulatory authorities and notified bodies.
- Monitor regulatory changes and ensure timely adaptation of internal processes.
- Performs internal reviews to confirm compliance with QMS and regulatory standards
- Support internal teams (R&D, Clinical) to ensure compliance across the product lifecycle.
- Coordinate and provide guidance during audits, inspections, and certification processes.
- Train and mentor team members on regulatory best practices.
EXPERIENCE
- 4–6 years of experience in regulatory affairs for medical devices or diagnostics.
- Proven experience with IVDR and/or FDA regulatory pathways.
- Proven experience of Notified Body submissions and audits for CE Mark or ISO 13485
- Professional Relationship: Employment contract
- Type of Contract: Permanent
- Nº Weekly Hours: 39 hours
- Work Schedule: Flexible, 9h - 18h aprox.
- Annual Gross Salary: 45000 - 55000 + 10% bonus (based on objective achievement) NEGOTIABLE SALARY ACCORDING TO EXPERIENCE
