Regulatory Affairs Officer

We are looking for a "Regulatory Affairs Officer" to strengthen our Regulatory Affairs departement.

Your mission :

The RA Officer is a key professional within our company specializing in in vitro diagnostics and will be responsible for :

• Ensuring that all of the company's products comply with national and international medical device regulations.
• Ensuring the conformity of our products and compliance with quality standards.

She/He will work closely with the product development, quality, sales teams and regulatory authorities.

Your tasks :

• Regulatory compliance: 
  - Identify and interpret regulatory requirements for in vitro diagnostic products, including standards from the EU, FDA and other regulatory authorities. 
  - Constantly monitor current regulations in the field of in vitro diagnostics
  
  
• Documentation and submissions: 
  - Manage and maintain regulatory documentation: technical files, information on national portals, EUDAMED, etc. 
  - Prepare and submit marketing authorization application files.
  
  
• Internal coordination: 
  - Work closely with product development teams to ensure new products are designed with regulatory requirements in mind. 
  - Provide regulatory advice to R&D, production, sales and quality departments. 
  
  
• Audits and inspections: 
  - Prepare and coordinate internal and external regulatory audits. 
  - Manage regulatory authority inspections and interactions with them. 
  
  
• Contact with authorities and notified bodies: 
  - Establish and maintain constructive relationships with regulatory authorities, regulatory representatives, and relevant notified bodies. 
  - Coordinate discussions, meetings and communications with these entities to ensure mutual understanding of the company's products and processes.

Your profile :

• Engineering degree or master's degree in life sciences, pharmacy, biology or a related field.
• Initial experience in regulatory affairs for medical devices, pharmaceuticals or bioproduction is required
• English proficiency
• Be familiar with the use of the office suite and ideally an ERP tool
• Knowledge of regulations related to IVD is an asset
• Be organized, reliable and have integrity.

What we offer ?

• A job in a family business on a human scale where you will have regular contact with all of your colleagues and managers;
• A full-time position and daytime schedule from Monday to Friday with flexible schedule (day start time between 7:30 a.m. and 9 a.m.);
• Numerous extra-legal benefits (full DKV insurance, supplementary pension insurance, meal vouchers worth €8, etc.);
• From 34 to 40 days of leave per year (depending on seniority);
• Individualized training course.
• The possibility of carrying out part of the work, after an integration period, by teleworking.

How to apply ?

You are interested ? Then send your CV and cover letter to :
 HR@diasource.be with Ref. RA Officer

Your application and related information will be treated with strict confidentiality.