Manager Quality Assurance & Reg Affairs | AirStrip | Remote

Responsibilities include, but are not limited to:

• Develop, implement, and maintain QSDs in order to assure compliance of the Company’s Quality System with MDSAP, 21 CFR Part 820 and any other FDA guidance and regulations related to SaMDs
• Participate during audits conducted by Notified and Regulatory bodies by providing professional support and expertise for Quality Assurance and Regulatory Affairs topics
• Act as team member of New Product Development (NPD) or Existing Product Enhancement (EPE) Teams during all phases of the development of the Design History Files (DHFs)Technical Files (TFs) as wells as Risk Management, Clinical Evaluation or Post-Market Surveillance Files.
• Participate in the Nonconforming Product and Complaint Processes in order to identify, document, evaluate, segregate and disposition in a timely manner the Nonconforming Product and/or Customer Complaints.
• Solve the systemic Product Non-Conformances (NCs) through the Corrective Actions Preventative Actions (CAPA) Process in order to eliminate or prevent the occurrence of these NCs
• Participate in and ensure timeliness of Internal and Supplier Audits according to the Company’s Audit Programs and current standards and regulation requirements
• Organize and coordinate the CAPA, Complaints, Clinical Evaluation and Post-Market Surveillance data collection, monitoring, analysis and report for the Management Review meetings
• Maintain international authorizations including but not limited to ISO 13485:2016, MDSAP, MDD/ MDR Certifications, UKCA, and CMDCAS registrations, as well as the regulations that apply to any area the Company determines are in its best interest.
• Establishing compliance “knowledge base” that can be mined to extract compliance statistics and current regulations
• Builds expertise over time on various topics such as Cloud computing Directly supervises the QA/RA Associate Project Manager
• Implementing ongoing, proactive compliance decisions for items listed above to include European Conformity (CE) requirements
• Upgrade processes to meet the upcoming MDR requirements
• Implementing proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in designated markets
• Participate in AirStrip response to compliance questionnaires for Enterprise Users
• Hands on work to ensure corporate SOPs comply with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles

Education & Experience Requirements

• Bachelor's degree in Healthcare, IT, Quality, or related field (commensurate experience will be considered in lieu of degree)
• Minimum 5 years of experience managing QA / RA in a medical device company
• Minimum 5 years of experience understanding guidance’s from FDA and international regulatory agencies.

Required Knowledge, Skills, and Abilities:

• Strong organizational, planning, and follow-up skills
• Strong interpersonal communication (written and verbal)
• Effective problem-solving skills; results-oriented
• Outstanding attention to details
• Creative and innovative thinker
• Coaching and mentoring for direct reports
• Continuous improvement for QMS
• Proven compliance with the current and applicable standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, QMSR, etc.
• Strong understanding of risk assessment

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.