Regulatory Affairs Specialist

Job purpose 

Regulatory standards need to be met wherever and whenever RKW markets their products. This job aims to ensure that current laws and guidelines are reflected in RKW’s systems and processes, and that amendments are consistently monitored and followed up. The job holder will also provide support and trainings on regulatory affairs and represent RKW in select regulatory bodies. 

KEY DUTIES AND RESPONSIBILITIES 

1. Make sure RKW complies with applicable standards and regulations related to individual products and markets (e.g. 10/2011/ Reach / 1935/2004). The job holder will be the main point of contact for regulatory affairs, give guidance, and conduct trainings for relevant counterparts as required.
2. Develop, introduce, harmonize, control and improve RKW’s regulatory affairs standards on a global scale.
3. Support Group QHSE & Supplier Quality Manager
4. Preparation of declarations of conformity and opinions on the absence of substances after review of the complete formulation of the Company’s products, which shall include European and United States legislation, and any other legislation.
5. Obtain declarations of conformity from the Company’s suppliers in order to ensure that the products of the Company’s suppliers comply with the relevant legislation and that the necessary tests have been carried out, as well as to arrange for any necessary tests to be carried out on the packaging material.
6. Preparation of certificates in addition to declarations of conformity previously issued. Responding to questions from the Company’s customers, processing special inquiries, and providing written and verbal information. Dispatch of declarations of conformity already drawn up or certificates already issued.
7. Represents RKW in regulatory bodies and adheres to RKW’s code of conduct and represents RKW in a professional manner.

JOB QUALIFICATIONS

(Minimum requirements): 

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.   

Education and Experience 

• Bachelor degree, chemistry desired  
• Experience in Regulatory Affairs on a global scale  
• Analytical skills  
• Risk Management techniques (e.g. FMEA etc.) 
• Audit skills  

Essential Skills and Hard Skills

(includes training, licenses, credentials & languages) 

• Business fluent English and German skills 
• Knowledge and experience with regulatory authorities 
• Experience in communication with Notified Bodies  
• Product compliance skills (10/2011; FDA; 1935/2004; China Food   
• Legislation, 94/62/EG; etc.) 
• Train the Trainer  
• Experience with quality management systems 
• Knowledge in ISO Standards  
• Ability to communicate in an intercultural environment 
• Ability to travel worldwide up to 30%
  

Personne de contact

Jason Descamps