Are you ready to link your passion with a purpose? At AirStrip, we build technology that enables clinicians to diagnose earlier than ever before, accelerate life-saving interventions, reduce the cost of care, and save lives.
We provide mobile-first clinical surveillance and alarm communication management technology that unlocks siloed data from patient monitors and transforms it into contextually rich information easily accessible on mobile devices and the Web. We’re seeking innovative thinkers who love doing meaningful work. If you’re looking to bring your skills and expertise to a growing technology company, it’s time for you to join us!
AirStrip is adding a Vice President of Quality Assurance and Regulatory Affairs (QA/RA) to our team. This role is a strategic executive leader responsible for establishing, maintaining, and advancing AirStrip’s global Quality Management System (QMS) and regulatory compliance framework in support of its Software-as-a-Medical-Device (SaMD) product portfolio. This role ensures alignment with applicable regulatory requirements including FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, MDSAP, EU MDR 2017/745, UK MDR, Health Canada, and other international standards. The VP of QA/RA serves as the organization’s Management Representative and oversees regulatory strategy, quality operations, compliance governance, and audit readiness across all markets where AirStrip products are developed, marketed, and distributed. This role is accountable for ensuring product safety, effectiveness, cybersecurity compliance, and regulatory approvals that enable continued commercialization and market expansion. This position offers the ability to working remotely within the United States, or in a hybrid capacity out of our office in San Antonio, TX.
Responsibilities include, but are not limited to:
- Establish, Maintain, Audit and Continuously Improve of the Company’s Quality Management System (QMS), Regulatory and other elective Compliance Programs.
- Responsible for the overall leadership of QA/RA Department functions, budget and development.
- Working with Company’s Executive Team to align the QA/RA Department activities with the Company’s evolving business strategy needs.
- Coordinate, develop, implement and maintain QSDs in order to assure compliance of the Company’s Quality System with MDSAP, ISO 13485, 21 CFR Part 820 and any other standards and regulatory guidance and requirements related to SaMDs.
- Provide professional support and expertise during MDSAP, ISO and FDA Audits by acting as a Subject Matter Expert (SME) for QA/RA topics.
- Develop the Regulatory Strategies and the content of the Premarket Submissions and/or Premarket Approvals (PMAs).
- Supervise the development and revise as well as approve the completion of the Risk Management Files, Clinical Evaluation Files, and Engineering documentation for the Projects.
- Oversee the Post-Market Surveillance Activities and Reports along with the Supplier Management Processes and report during the Management Review meetings
- Act as a member of the Management Review Board (MRB) in order to review and approve the Corrective Actions Preventative Actions (CAPAs) for the elimination or prevention of the occurrence of the Product and/or Process Nonconformities
- Ensure the conformity of the MDSWs/SaMDs is appropriately checked, in accordance with the QMS before the MDSWs/SaMDs are released.
- Monitor and maintain all company’s certifications and registrations that apply to any area the Company determines are in its best interest.
- Proactively develop Regulatory Strategy for a very efficient compliance of the Company’s Products and QMS with the current FDA Regulations.
- Coordinate the review and update of the Company’s QMS according to the current FDA Quality System Regulations (QSR).
- Act as an independent reviewer during all phases of the development of the Design History Files (DHFs) as wells as Market Releases
- Responsible for leading all the activities required be the Medical Device Reporting (MDR), including, when require, the Recall Activities and Documentation.
- This position is designated as the Management Representative under 21 CFR 820.20(b)(3) and is responsible for coordination of Management Review.
- Ensuring the ongoing and proactive compliance strategy with European Conformity (CE) requirements under the Medical Device Regulation (MDR).
- Assume the role of the designated Person Responsible for Regulatory Compliance (PRRC) under the EU regulations.
- Act as an independent reviewer during all phases of the development of the Technical Files (TFs), as wells as Product Registration.
- Coordinate all the activities related to Risk Management and post Markey Surveillance under ISO 24971, respectively MDR.
- Responsible for leading all the activities required be the Medical Device Vigilance System (MDVS), including the development or review of the Vigilance Reports.
- (Australia compliance): ensuring proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in the Australia market and affiliated markets.
- (Japanese compliance) ensuring proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in the Japanese and affiliated markets.
- Ensuring proper compliance with HIPAA and information security laws of countries where AirStrip products are sold.
- Assume required duties for Privacy Official (HIPAA/GDPR) regulatory requirements
- Principle designated to report on the performance of the ISMS designated Security Official
- Manages and ensures compliance with ISO 27001 and coordinates auditing of the system for compliance.
- Coordinates AirStrip response to compliance questionnaires for Enterprise Users.
Education & Experience Requirements:
- Bachelor's degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline
- Lead Auditor Certification for ISO 13485 and/or ISO 27001
- Minimum 10 years of experience with Software As a Medical Device and/or Software-Controlled
- Minimum 10 years of demonstrated leadership skills in quality and regulatory compliance in the medical device industry.
- Minimum 10 years of experience in dealing with FDA and global regulatory agencies
Required Knowledge, Skills, and Abilities:
- Ability to effectively lead and manage, coach and mentor a team
- Business Awareness – Knows what AirStrip does and how AirStrip does it. Is aware of competitors. Up-to-date with general business and regularity news. Aware of developments in the sector. Thinks about regularity implications. Understands the importance of customer satisfaction and shareholder value.
- Analysis/Problem Solving – Able to identify and separate out the key components of problems and situations. Can generate a range of creative solutions, evaluate them and choose the most appropriate option.
- Teamwork – Actively participates in teams. Encourages co-operation. Aware of the needs of others and responds flexibly. Prioritizes team goals over individual goals.
- Communication – Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication.
- Self Confidence/Resilience – Measured confidence to take on demanding work or put forward views when they may be challenged. Stays calm in a crisis. Handles competing demands. Overcomes setbacks. Welcomes and learns from criticism.
- Judgement/Decision Making – Takes balanced view of situations incorporating different perspectives. Seeks alternative viewpoints. Recognizes priorities, weighs up different options and evaluates risks.
- Researching And Investigating – Has the ability to recognize information needs and identify and utilize appropriate information sources. Persists in seeking information and adopts a variety of strategies. Questions, checks and evaluates information and sources. Pays attention to details.
- Planning And Organizing – Able to achieve results in a quality, timely, and cost-effective way. Sees priorities, plans the efficient use of resources, and monitors progress against objectives. Anticipates crucial stages in projects. Formulates alternative means of achieving objectives. Responds effectively to unforeseen events.
The salary range for applicable US-based applicants to this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. $160,000 - $205,000 base salary plus bonus potential.
We value each of our employee’s total wellness. From robust medical, dental, and vision insurance, to financial planning assistance, to physical and mental wellness discounts, and unlimited access to our online learning platform, we understand that our company succeeds when our employees succeed as individuals.
Additional notable US-employee benefits include:
- Paid Time Off (hourly) / Flex Time Off (salaried) programs for Full Time employees
- Growth and Development opportunities
- 401(k), including a 3% company match
- Paid Holidays
- Paid Parental Leave, including a flexible return-to-work program
- Employee Assistance Program
- Discounts on popular cell phone plan providers
- Life & Disability Insurance
- And more!
AirStrip provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Originally posted on Himalayas