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Senior Quality & Regulatory Affairs Specialist

Senior Quality & Regulatory Affairs Specialist

Job Title: Senior Quality & Regulatory Affairs Specialist
Contract Type: Permanent
Location: Zürich, Switzerland
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: HQ00117942_1580129672
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: January 27, 2020 12:54

Job Description

Our Client:

A company in the Swiss town of Zurich, focused on a wearable device, smart app and proprietary predictive algorithms for women.

Job Description:

  • Ensure compliance with all relevant regulations in the US, Europe, China and other countries
  • Liaise with notified bodies and authorities to support implementation of the global regulatory strategy and expedite regulatory approvals
  • Prepare, submit and maintain regulatory dossiers in the US, Europe, China and other countries
  • Provide input to the development of technical files and update of procedures in light of the revised Medical Device Regulation 2017/745
  • Support Post Market Surveillance activities and ensure compliance with post-market approval requirements
  • Advise the device development team as an active member on product development, manufacturing changes, technical labeling and ensuring interpretation of the appropriate regulations
  • Implement risk management measures in accordance with EN ISO 14971 and the internal risk policy
  • Assess the acceptability of verification and validation documentation for submission
  • Review and monitor controlled records supporting Ava's Quality Management System (QMS) and advise management/quality of updates to quality management procedures to ensure effective function in line with Ava's quality objectives
  • Assist in corrective action implementation and closure for both projects and QMS compliance issues
  • Communicate Ava's QMS to auditors or customers and promote awareness of applicable regulatory requirements and QMS requirements throughout the organization

The ideal candidate:

  • Motivated by our mission to make a real difference in women's health
  • Bachelor's degree in natural science, engineering, computer science or equivalent from a renowned university
  • A minimum 4 years of experience in medical device quality and/or regulatory affairs
  • Track record of driving quality assurance and aligning product and organizational environments Sound understanding of product development incl. clinical trials / Good Clinical Practice (GCP) and how they affect the regulatory approval timeline in different territories
  • Strong working knowledge of FDA regulatory pathways (510(k), de novo), CFR 21 Part 820, ISO 13485 and MDR are a must; knowledge of Chinese regulations is a strong plus; any other regulations are a nice to have
  • Knowledge of medical software incl. firmware, apps, and cloud-based algorithms are a strong plus
  • Highly motivated, entrepreneurial and pragmatic personality who enjoys working in a very dynamic organization with global ambitions
  • Strong analytical skills to drive complex regulatory decisions in an area with a lot of regulatory uncertainties (wearable devices, apps, artificial intelligence, machine learning)
  • Strong communication skills and the ability to work independently and manage multiple, competing priorities
  • Able to work with advanced IT tools to make processes user-friendly and efficient
  • Fluent in English; additional languages welcome
  • EU or Swiss citizen, or valid Swiss work permit

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: