Director of Compliance and Regulatory Affairs

16 Jun, 2020

Jobs

Director of Compliance and Regulatory Affairs

Ambra Health
Remote

Ambra Health

Director of Compliance and Regulatory Affairs

Company Background

Ambra Health is a healthcare SaaS company that provides secure and simple access to medical images in the cloud, reducing unnecessary and redundant tests, lowering radiation exposure to patients, and making medical images immediately available to improve patient care. With nearly one billion images in our care today, we work with leading U.S. hospital systems and healthcare organizations.

A career at Ambra Health offers you the opportunity to join a dedicated team of professionals who are changing the face of healthcare IT. We’re always on the lookout for kindred spirits who are hungry to make a dent in something big and meaningful. We encourage work-life balance and believe that you should be rewarded for your abilities and hard work.

Job Description

For the Director of Compliance and Regulatory Affairs role, Ambra Health is seeking a highly motivated, skilled professional to join our team. You will be tasked with ensuring Ambra Health remains compliant within all areas of the company; this entails conforming with HIPAA, the FDA Quality System Regulation, the European Medical Devices Regulation, ISO 13485, and other regulatory requirements.

Responsibilities

  • Ability to interface with regulatory agencies; execute and manage global submissions with timely approvals
  • Manage internal, external, and supplier audits
  • Lead risk management activities according to risk management plans
  • Monitor regulations and communicate impact of changes
  • Ensure compliance training and adherence
  • Participate in new product enhancement and change reviews to assess regulatory risk
  • Manage CAPA, complaint handling, document control, and vendor management processes
  • Oversee, improve, and maintain all documentation and records that pertain to the informational security and quality management systems
  • Review and approve labeling in accordance with product registrations
  • Analyze and report quality metrics/state of the quality management system to Executive Management on a periodic basis

This is a client-facing role with significant responsibilities that requires professionalism and creativity. You will be expected to develop expertise in the Ambra Health application for when troubleshooting compliance issues. Domestic travel opportunities are common.

Qualifications:

  • Bachelor’s Degree and, ideally, additional professional certification in risk or compliance (e.g., CMQ/OE, CQE, CRE, RAB/QSA, RAC-US, etc.)
  • Experience in medical technologies, hospital administration, or equivalent experience for what the position demands
  • Five-years of experience working in compliance, quality, and regulatory affairs for a pharma or biotech company
  • Three-years experience in project management
  • Experience in the creation, documentation, evaluation, and improvement of quality metrics
  • Clear understanding of medical device software processes and international quality management systems
  • Thorough knowledge of ISO standards, such as ISO 14971, ISO 13485, ISO 27001, and ISO 62304
  • Experience working with audits, both internal and external
  • Expert communication and collaboration skills
  • High enthusiasm and desire to work on an entrepreneurial team
  • Ability to write/present ideas clearly

Heavy emphasis will be placed on problem-solving skills, personal initiative and good people management/relationship skills. A roll-up-the sleeves attitude and sense of humor are mandatory.

This role offers a competitive salary and benefits, an awesome team, and the opportunity to be a part of something that is fundamentally changing the healthcare IT landscape.

This is a remote position

Learn more here

Job posted: 2020-06-16