(Senior) Regulatory Affairs Officer
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Zuid-Holland Netherlands.
The company is an innovative medical device company specialised in development and production of surgical instruments.
ROLE DESCRIPTION
To strengthen the team they are looking for a new Senior Regulatory Affairs Specialists. You will develop and maintain all technical documentation regarding all medical devices of the company and where needed improve these processes and documentations. Though working with the QA team you will focus on the Post Market Surveillance and Complaint handling.
RESPONSIBILITIES
Your main responsibility will the to take on the task of Complain handling and the full Post Market Surveillance cycle. As the new RA specialist you will support implement and safeguard compliancy of RA affairs and documentation. Other responsibilities would be:
• Support registration all products in concerning countries where the company has business or want to have business.
• Advising and counseling to the strategy concerning Regulatory affairs based on the Complaint handing results.
• Conducting and assessing plans, protocols and reports for verification and validation with the team
REQUIREMENTS
• At least one year experience in PSM regulatory within the medical device industry
• Experience with Complaint Handling in Post Market Surveillance
• Working experience with ISO 13485 is a plus
• Fluent in Dutch and English is a must
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.