Regulatory Affairs Analyst

As an RA analyst, you will:

• Prepare regulatory submissions and conformity assessments for regulatory authorities
• Support the company’s regulatory activities by analyzing regulatory requirements in diverse territories and continually monitoring the regulatory environment
• Assist in preparation, review, and submission of marketing authorization applications
• Promote the company’s quality management system
• Contribute to development and implementation of regulatory strategies, including assessing regulatory impact on product development
• Collaborate with cross-functional teams such as R&D, product, and clinical teams to support regulatory submissions
• Support the preparation and maintenance of technical documentation and regulatory files in compliance with applicable standards (ISO 13485, 21 CFR 820. IVDR)
• Provide ongoing support to quality management activities
• Support post-market surveillance activities

The ideal candidate will have:

• A relevant bachelor’s degree (eg. law, industrial engineering, biotechnology engineering, life science, exact science)
• Minimum 2 years experience in medical devices RA
• Knowledge of US and EU regulations (experience with an IVD medical device - advantage)
• Understanding of quality assurance processes and methodologies (ISO 13485:2016, ISO 9001:2015 or similar)
• A motivated, collaborative, and proactive approach to work
• Ability to collaborate effectively with cross functional teams, including R&D, product, quality assurance and marketing to achieve regulatory objectives
• Excellent communication skills (both written and verbal)
• Strong attention to detail
• English proficiency