Quality and Regulatory Affairs (QA/RA) Officer

Rapidemic is seeking a Quality and Regulatory Affairs Officer with experience in ISO13485 and in vitro diagnostics to join its growing team. In this role, you will set up the company’s quality processes, conduct audits and ensure the company reaches its quality and regulatory goals. You will be working closely with the R&D team to ensure compliance with the newly developed processes.

Rapidemic B.V. is a young and dynamic medtech start-up company, dedicated to making molecular diagnostics easy and accessible to all. Our first product is a decentralized test for fast and accurate diagnosis of highly prevalent sexually transmitted infections. We are located in the heart of the Leiden Bioscience park, in BioPartner 3.

Location: BioPartner 3, Leiden Bioscience Park, Leiden. 

Type: Full-time position, 40h/week (part-time work possible)

Contract: Temporary, 1 year contract with possible extension

Start: As soon as possible. Latest September 2024. 

Deadline to apply: 31/7/2024

Responsibilities

• Ensure compliance with industry standards and regulations for a molecular diagnostic test.
• Lead in the development, implementation, and maintenance of quality management systems (QMS).
• Conduct internal audits and support external audits to ensure adherence to quality standards.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Lead the development and revision of standard operating procedures (SOPs) and quality documentation.
• Lead the validation and qualification of laboratory equipment and processes.
• Contribute to continuous improvement initiatives to optimize product quality and operational efficiency.
• Interact with notified body and medical device certification consultants and provide guidance for the R&D team on e.g. CE Marking, product registrations, and clinical evaluations.
• Ensure clear communication with external consultants.

Profile

Soft skills:

• Ability to work under pressure.
• Strong analytical skills, with attention to detail.
• Excellent communication and interpersonal skills.
• Self-motivated, independent and proactive.
• Pragmatic.
• Ability to prioritize tasks and manage time efficiently to meet deadlines.

Hard skills

• A HBO or Bachelor’s Degree in a Life Sciences related degree.
• Over 3 years of experience in a QA/RA role within the in vitro diagnostics or medical device industry.
• Working experience with ISO 13485 and other relevant quality standards and regulations.
• Previous experience with the IVDD or IVDR 2017/746 and medical devices.
• Experience supporting/leading internal and external quality audits.
• Experience setting up procedures and related documentation from scratch.
• Project management
• Preferred: experience with electronic QMS.

Offer

• A full-time position – part-time options can be discussed.
• A position in a quickly growing company in the vibrant Leiden Bioscience Park.
• A relaxed work environment and flexible working hours.
• Opportunities for training & personal development. 

Other information

For application, please send your CV and short cover letter (combined into one PDF) to info@rapidemic.com with the job title in the header.

We look forward to receiving your applications! 

Violette Defourt
CEO
info@rapidemic.com