Regulatory Affairs Specialist

vor 1 Monat

Eysins, Schweiz AliveDx Vollzeit
Job Title: Quality & Regulatory Affairs Specialist

At AliveDx, we are committed to empowering diagnostic insights, transforming patient care, and innovating for life. With over 30 years of experience in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results.

Job Summary:

We are seeking a highly skilled Quality & Regulatory Affairs Specialist to join our Regulatory Affairs & Quality Department. The successful candidate will be responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.

Key Responsibilities:

  • Maintain product and site regulatory & quality compliance to ensure license/registration is maintained.
  • Support other regulatory and quality affairs team members as needed, including training and guidance.
  • Prepare and compile regulatory documentation, coordinate and execute regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements.
  • Advise AliveDx staff and project team members on data and information required for successful license applications and coordinate their efforts to ensure their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations for AliveDx Suisse SA.
  • Ensure Supplier management obligations for AliveDx Suisse SA.
  • Ensure Post-market surveillance obligations for AliveDx Suisse SA.
  • Ensure vigilance reporting obligations for AliveDx Suisse SA.
  • Be a point of contact for regulatory & quality compliance issues.
  • Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
  • Evaluate Product/Processes Non-Conformances, determine whether they need to be reported to the Competent Authorities.
  • Support QMS organization during regulatory inspections or certifications audits.
  • Perform any other duties as reasonably requested from the Company from time to time.
  • Conduct all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.

Requirements:

  • Master's degree or equivalent in life sciences and significant experience in a regulatory/quality role.
  • Experience in medical device / IVD / biotech industry.
  • Experienced in meeting with, making presentations to, and negotiating with regulators.
  • Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc).
  • Specialist knowledge of vigilance processes for US, EU, and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.).
  • Effective time management and prioritization skills.
  • Ability to work in an international team in a fast-paced changing environment.
  • Great attention to detail with a thorough and methodical approach to work.
  • Communication skills.

What We Offer:

  • A highly dynamic and growing environment.
  • An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
  • A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days, and access to marketplace discounts.

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