Regulatory Affairs and Quality Assurance Senior Specialist
Job Title: | Regulatory Affairs and Quality Assurance Senior Specialist |
Contract Type: | Permanent |
Location: | Lausanne, Switzerland |
Industry: | |
Salary: | Negotiable |
Start Date: | ASAP |
Reference: | HQ00119440_1581504648 |
Contact Name: | Michael Burgstaller |
Contact Email: | m.burgstaller@sciproglobal.de |
Job Published: | February 12, 2020 10:50 |
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

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