Regulatory Affairs Specialist

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