We are looking for a regulatory affairs (RA) analyst to join our compliance and RA team. The team is responsible for our regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.
As an analyst, you will:
Prepare regulatory submissions and conformity assessments for regulatory authorities
Support the companys 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 companys 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 our quality management activities
Support post-market surveillance activities
As an analyst, you will:
Prepare regulatory submissions and conformity assessments for regulatory authorities
Support the companys 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 companys 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 our quality management activities
Support post-market surveillance activities
Requirements:
A relevant bachelors 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
A relevant bachelors 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
This position is open to all candidates.
