Regulatory Affairs and Quality Assurance Senior Specialist

Regulatory Affairs and Quality Assurance Senior Specialist

Job Title: Regulatory Affairs and Quality Assurance Senior Specialist
Contract Type: Permanent
Location: Lausanne, Switzerland
Salary: Negotiable
Start Date: ASAP
Reference: HQ00119440_1581504648
Contact Name: Michael Burgstaller
Contact Email:
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:
  • 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:

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