REGULATORY AFFAIRS ASSOCIATE
GenDx is hiring a RA Associate to support the development of new products from early on, ensuring compliance with regulatory requirements.
As Regulatory Affairs Associate at GenDx, you are involved in the development of new products, starting at an early stage, by integrating regulatory principles in preparing and submitting technical dossiers to the applicable authorities. For this, you work intensely with other teams in GenDx.
Responsibilities
▪ Support the regulatory guidance regarding development, evaluation, and/or marketing of current and new products.
▪ Interpretation and implementation of regulatory requirements to newly developed products.
▪ Ensure accuracy and compliance with regulatory standards.
▪ Collaborate with Regulatory Authorities.
▪ Support and monitors the implementation of complaint processing systems
▪ Support activities such as audits and/or product recalls.
▪ Working according to ISO 13485 standards.
Requirements
▪ PhD in molecular biology (or equivalent) or acquired level through working experience.
▪ Effective in communication.
▪ Outstanding in keeping overview with attention to detail.
▪ Comprehensive work style.
▪ Excellent command of Dutch and English (written and spoken).
▪ You live in the Utrecht Science Park area, or are willing to relocate.
What’s on offer?
▪ Becoming part of a driven, ambitious team, within an international working environment.
▪ Competitive salary.
▪ A pension scheme.
▪ Compensation for commuter traffic and working from home.
▪ Employment based on a 40 hour work week.
▪ Option to work from home one day per work week.
▪ Laptop.
▪ 31 holidays, including 6 collective leave days.
▪ Sport pass for Sports Center Olympos.
Information
For more information, you can contact Erica Kremer PhD, Director Compliance, at 030 252 37 99.
Do we match?
Join the experts in transplant diagnostics! Do you want to be part of an innovative company that offers excellent working conditions and ample time for personal development? Apply now and maybe you will soon be part of the GenDx team.
Send your CV and motivation to Roelien Brommersma MSc, CHRO, hrm@gendx.com.
Please mention your name in the e-mail subject line, as well as ‘2023_08’.
Unsolicited third party/agency profiles and resumes will not be considered
