Director of Quality and Regulatory Affairs
iRhythm Technologies, Inc. is a San Francisco-based medical device startup company combining novel device and data analysis concepts together to create a new approach to cardiac rhythm monitoring. iRhythm is looking for an experienced quality and regulatory leader to manage the team responsible for overseeing the quality, safety and effectiveness of iRhythm's hardware and software products, and also for ensuring that the company maintains strong compliance with both domestic and international regulatory bodies.
San Francisco, CA
Executive VP, Research & Development
This role will be responsible for managing all aspects of iRhythm's quality and regulatory affairs, directing iRhythm's QA/RA team and actively engaging to ensure timely and compliant operation of iRhythm's Quality System. This role will also address tactical and strategic aspects of regulatory compliance. Specific responsibilities include:
- Supporting product quality through enforcing iRhythm's Quality System, FDA guidelines for Current Good Manufacturing Processes (cGMP), and ISO 13485.
- Reviewing product complaints and field returns in order to direct appropriate quality and regulatory actions; overseeing the corrective and preventative actions that result.
- Monitoring product and manufacturing process quality trends; proactively identifying issues and leading appropriate investigations and/or actions.
- Identifying and leading the evolution of iRhythm's quality assurance programs to ensure ongoing effectiveness and regulatory compliance.
- Communicating quality and regulatory performance to senior management, both at regular intervals and more proactively when required.
- Developing, administering and maintaining regulatory-oriented programs, procedures and controls to ensure company compliance with all external regulatory agency (state, federal and, where applicable, international) requirements.
- Reviewing specifications, protocols and reports, engineering change notices, nonconforming materials, and failure analyses to ensure quality and regulatory compliance.
- Reviewing labeling, advertising, sales support, marketing literature, and training materials for regulatory compliance.
- Participating on and/or providing regulatory support for new product design/project teams.
- Defining the regulatory approach, and subsequently lead efforts to prepare and obtain clearance of domestic 510(k) and international CE product submissions for new products, and for existing product renewals and registrations, as appropriate.
- Performing and/or coordinating internal and supplier audits in compliance with our Quality System; leading the response to external audits.
- Maintaining and preparing, as appropriate, regulatory affairs files such as technical files, device listings, certificates, licenses, etc.
- Evaluating the impact of regulatory changes to existing products and recommending strategies to facilitate the transition; communicating impact to management.
- Bachelor's degree required in Engineering, Regulatory Science, or related medical/science field.
- Minimum of 8 years of professional experience in engineering and/or quality and regulatory roles in the medical device field, with a requirement of at least 4 years of progressive experience in quality and regulatory affairs.
- Strong knowledge of both domestic and international device laws and regulations, including applicable cGMP / FDA CFR 820 Part 21 / MDD / ISO 13485 requirements.
- Management experience with demonstrated track record of successful recruiting, retention and team leadership.
- 510(k) submission experience for a medical device or diagnostics company.
- Familiarity with regulatory and quality issues surrounding both hardware and software medical device products.
- High-level analytical skills and ability to focus on detail.
- Excellent written and verbal communication skills.
- Demonstrated comfort working in a dynamic, entrepreneurial environment where strong organizational, leadership and communication skills were required to be successful.
- Proven capacity to build positive relationships and trust over time with cross-disciplinary audiences.
- Ability to correctly spell iRhythm in all documentation files (read: excellent attention to detail, not to mention strong communication skills – both written and oral).
- Advanced degrees and/or professional certification in regulatory affairs, quality management and auditing (e.g., CQM, CQE, CSQE, RAC and CQA certifications).
- Exposure to setting up and refining processes and systems in new environments – ideally from experience with other startup or small companies.
- Demonstrated passion and interest in how innovation can lead to better and more cost-effective healthcare.
- A good sense of humor is always a plus.
This is a full-time position. We offer an excellent benefit and salary package.
This fast paced company is looking for the right candidate to join us at this exciting time in our development. Qualified candidates should submit their resume including salary requirements to firstname.lastname@example.org. Due to the volume of applications we receive, we will only respond to those people whom we intend to interview.