Regulatory Affairs and Quality Assurance Senior Specialist

Job description

Our Client:

A Medtech Startup with Head office at EPFL Innovation Park in Lausanne. The mission of our client is to develop, manufacture and commercialize a medical device able to accurately monitor and relieve sleep bruxism using an innovative treatment, a solution for 60 millions of peoples worldwide.

Job Description:

• Cover role of PRRC within the team
• Support the management in decision-making concerning QA and RA matters, incl. regulatory strategy
• Implement and manage an ISO 13485-compliant QMS, including aspects of PMS
• Author and maintain Quality Manual, SOPs, policies and records
• Support the team in generating the required documentation and ensuring product compliance, incl. technical documentation
• Lead internal quality audits, lead/support supplier audits
• Manage pre-submission interactions with FDA
• Lead preparation, submission and maintenance of regulatory dossiers in Europe, US, incl. submission to ethical committees, competent authorities and notified bodies
• Manage communications with regul

The ideal candidate:

• Master or PhD in science, engineering, medicine, pharmacy, or equivalent
• Over 4-year experience in a similar role in the medical device industry (QA / QM / RA / Clinical Affairs) * Good knowledge of regulatory requirements for medical devices and relevant standards
• In-depth knowledge of European (MDR) and FDA regulatory pathways (510(k), de novo, PMA)
• Experience with ISO 13485 requirements, processes and procedures; good knowledge of QSR * Experience with ISO 14971
• Experience with ISO 14155 / GCP, good understanding of clinical trial management and post-market surveillance procedures
• Knowledge of Process Validation principles * Certification as Lead Auditor, to conduct internal and suppliers' audits
• Excellent communication skills and ability to work well with and train others, ability to work efficiently under high-pressure conditions
• Collaborative mind-set, excellent communication capacities, planning, organizing, and self-initiative skills
• Fluency in English (spoken and written)
• Willingness to join a multicultural fast-growing start-up team.

Application process:

• CV to: m.burgstaller@sciproglobal.de
• Phone call including a presentation of the company
• I take over the whole application process (from interviews to contract negotiations)
• Discuss also other suiting options tailored towards your profile

My Contact:

• E-Mail: m.burgstaller@sciproglobal.de
• Tel: +41 43 508 92 17
• Xing: https://www.xing.com/profile/Michael_Burgstaller19/cv