QA/RA Specialist
Job description

Join one of the most promising company in the Swiss Medtech environment!

Abionic is committed to revolutionize the world of in vitro diagnostics with rapid universal point-of-care solutions, based on disruptive technology.

Abionic offers the world of healthcare a novel point-of-care diagnostic tool and thereby fills patient’s unmet needs. Abionic is a fast-growing company with ambitious objectives, a spin-off from EPFL and a proud member of Health Valley, located in the Lausanne area, Switzerland.

We are looking for a QA/RA Specialist to complete our team.

Your Tasks

We are looking for an experienced Specialist for Quality Assurance and Regulatory Affairs who is motivated to bring his/her expertise and experience to our company. In this central and multidisciplinary position, you will give important support to the Quality Assurance and Regulatory Affairs activities to ensure compliance with standards and regulations. You will report directly to the Head of QA/RA. Your main tasks will be to:

  • Participate in the preparation and maintenance of documentation for international and domestic product registrations.
  • Compile and review documents (including scientific summary reports) for medical device applications/technical files, public notary, etc
  • Collaborate to ensure regulatory compliance with QSR (21 CFR Part 820), ISO13485, IVDD/IVDR, corporate policies/procedures and other worldwide regulatory requirements as appropriate.
  • Ensure that Abionic’s Device Master Files and technical files are timely assembled and maintained up to date, according to the company’s QMS and the regulatory requirements.
  • Perform internal audits and prepare reports, including propositions for corrective actions where needed.
  • Support preparation and participate in external audits, as well as auditing of key suppliers. Prepare and ensure timely completion of corrective action plans.

Your Skills

  • Education in Life Sciences or Engineering with at least 2+ years of relevant professional experience in Quality Assurance and Regulatory Affairs in the IVD and/or Medical Device industries. Advanced degree preferred.
  • Strong capacity to manage multiple tasks in an autonomous and efficient way. Excellent capacity to interact with various partners, within the company and externally.
  • Previous professional experience in an ISO 13485-certified environment. Good understanding of FDA CFR Part 820, ISO 14971 and/or IVD regulations (IVDD/IVDR) is a plus.
  • Rigor, excellent organizational skills, attention to details, dedication and sense of responsibilities.
  • Ability to perform work independently and in cross-functional team projects in a fast-paced environment.
  • Language requirement: Fluent verbal and written English, knowledge of French is a plus.

She or he must be motivated to contribute to the development of a highly innovative company as part of our young, talented and ambitious team.

We Offer

  • A challenging job in an exciting and fast-growing company,
  • Integration in a dynamic team,
  • A highly innovative environment,
  • An opportunity to improve healthcare globally.

Key Information

  • Starting date: Immediately.
  • Activity rate: 80-100% (To be discussed)

Please send us your application (CV and a motivation letter) to jobs@abionic.com, mentioning “Position as QA/RA Specialist” in the headline.

Type of contract
80-100%
Location
Epalinges