Quality & Compliance Manager

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Overview

We are looking for a Quality & Compliance Manager to elevate the maturity of our processes and to drive us forward through the highly regulated landscape as a Software as a Medical Device (SaMD) company.

What you’ll be in charge of

As Quality & Compliance Manager you’ll be…

Implementing quality
  • Ensuring ongoing regulatory compliance of Healios with MedTech relevant guidelines and requirements such as ISO 13485, EU MDR and FDA.
  • Supports Healios with the completion and improvement of the Quality Management System and other compliance programs.
  • Supports multiple quality system functions, including but not limited to: Document Control, Record Control, Training, Complaints, Recalls, Supplier Quality Management, Corrective and Preventive AOK – in terms of approach wections (CAPA, SCAR); Design Assurance and Risk Management; Quality Planning; Quality Systems Metrics and Trending of Key Performance Indicators, Internal and External Auditing Programs.
  • Advices on regulatory changes that may impact the Healios’ goals and activities.
  • Acts as the primary Person Responsible for Regulatory Compliance (under EU MDR).
In this capacity the candidate:
  • Ensures devices released to markets comply with all relevant Quality and Regulatory regulations, directives, and standards (e.g. ISO 13485, MDR, Cybersecurity, labelling, HIPAA, GDPR).
  • Ensure that any investigational devices for the EU market conform to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution is taken to protect the health and safety of the subjects.
  • Ensure Post-market Surveillance, Incident Reporting, and Field Safety Corrective Action obligations are fulfilled.
  • Stays proactive, strategic and effective in the engagement with the Healios’ cross-functional team to ensure timely and successful delivery of results.

What we are looking for

  • 4+ years of relevant hands-on experience in medical device regulatory affairs and quality management systems, MDR, FDA and ISO 13485.
  • Extensive experience with SaMD, including strategic planning and deployment of an effective and efficient quality system.
  • Prior working with IT start-ups and personnel with limited exposure to medical device regulations.
  • Deep knowledge of IEC 62304 and ISO 14971, including their application to an Agile/Iterative software development process.
  • Prior experience with Agile/Iterative software development tools and eQMS tools. For example – Jira, Jama, TestRail, Greenlight Guru, MasterControl.
  • A minimum of a bachelor’s degree in law, medicine, pharmacy, engineering or another relevant scientific discipline.

What we’d like you have

  • IEC62304, ISO13485, ISO14971, ISO27001 systems relevant to building software as a medical device
  • Experience with validation of software development tools.
  • Knowledge of 21 CFR Part 11 and related guidance documents.
  • Good planning and operational skills.
  • Excellent verbal, written, and presentation communication skills
  • Full proficiency in English and Spanish
  • Strong sense of ambition, self-motivation and self-discipline
  • Strong attention to detail in a highly nuanced and niche industry
  • Outstanding organization skills and the ability to integrate different people and processes inside the company

Here’s the deal

We focus on improving the lives of people with neurological diseases. It’s that simple. There’s no small print. No quick fixes. Just big ideas and a commitment to getting it done.

But if we can succeed in achieving that, while ensuring our team can grow and shares in this collective sense of worth, then despite the sometimes hectic days and deadlines/long days and late nights, we’ll sleep well.

Whether you are a seasoned pro, or just getting started, your time with us will be one of constant growth. Being MedTech means we are at the crossroads of a highly regulated world where every decision has every day impacts on patients’ lives.

Perks

  • Competitive salary and incentives, based on experience and deliverables.
  • Freedom to divide your time between home and the office
  • Budget to set up and maintain your remote office
  • Employee stock option plan
  • Flexible and generous Spanish holidays
  • Evolve with a company at the forefront of technology and health

We look forward to planning the future with you.

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