For our partner in Neuroengineering, Kelly Life Sciences is looking for:
Senior Regulatory Affairs
(Permanent contract)
You will report directly to the Chief Operating Officer:
Your responsibilities:
- Define the regulatory strategy for the medical devices under development to enter the EU, Swiss and US markets
- Manage the interactions with relevant regulatory bodies and, as applicable, Ethics Committees pertaining to pre-market submissions and clinical study submissions for the medical devices under development
- Supervise the medical device development activities along the defined regulatory pathways, from the Regulatory and Clinical Affairs standpoint, in collaboration with the relevant internal and external stakeholders
- Define and maintain the Regulatory and Clinical Affairs processes within Quality Management System
- Ensure the compliance of medical devices' Technical Documentation with the applicable regulatory requirements
- Provide regulatory guidance and supervision to the risk management and usability engineering activities for the medical devices under development
- Lead regulatory intelligence and post-market surveillance activities in accordance with the applicable regulatory requirements
Your profile:
- Master's degree or PhD in Biomedical engineering or equivalent
- + 5 years of experience in Regulatory affairs
- Experience with class III medical devices is an asset
- Knowledge in EU, Swiss and USA medical device regulations
- Knowledge in MDR (EU) 2017/745, FDA 21 CFR Part 820 and ISO 13485
- Demonstrated experience in interacting with National Competent Authorities (FDAM Swissmedic, Bfarm)
- Fluent in English, proficiency in French a plus
Your contact at Kelly: Anaïs Mieszczak +41 22 737 12 05