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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
This managerial position within the QA/RA team is responsible for maintaining and implementing continuous improvements to the AirStrip Quality System, including such aspects as document control, the information security management system, the internal audit program, risk assessments, and maintaining associated records to substantiate compliance with MDSAP, ISO 13485, ISO27001. The position scope includes regulatory cleared medical software as a device and consumer software, currently combined into a unified platform called AirStrip ONE, which consists of patient monitoring, cardiology, and obstetrics. Domestic and international settings include the US, Europe, Australia, Canada and South America, Asia, Russia, and China.
Essential Duties and Responsibilities
Review of software releases
Consumer software app standalone and web-based software regulatory release (i.e. letter to file, 510k filings etc.)
Software usability testing planning and risk management oversight
Managing corrective and preventative action (CAPA) process
Monitoring compliance of complaint handling process with applicable policies and regulations
Appropriate Quality Management System oversight review per FDA and international Quality System Regulations
Review marketing materials and other labeling for compliance
Ensure timeliness of internal audits and perform such audit as applicable and follow up on resolution of findings
Help prepare the Management Review materials and conduct the Management Review presentation.
Implementing ongoing, proactive compliance decisions for items listed above to include European Conformity (CE) requirements
Upgrade processes to meet the upcoming MDR requirements
Therapeutic Goods Administration (TGA):
(Australia compliance): implementing proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in the Australia market and affiliated markets.
Japan Pharmaceutical and Medical Device Administration (PMDA)
(Japanese compliance) implementing proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in the Japanese and affiliated markets.
HIPAA / DIACAP / GDPR SECURITY:
Implementing proper compliance measures with HIPAA and information security laws of countries where AirStrip products are sold.
Information Security Management System
Implements and maintains compliance with ISO 27001 and coordinates auditing of the system for compliance.
Participate in AirStrip response to compliance questionnaires for Enterprise Users.
Builds expertise over time on various topics such as Cloud computing compliance (FEDRAMP, CE regulations, etc.).
Manage external audits by notified bodies
Perform outsourced manufacturing inspections as needed
Coordination of consensus standard identification and compliance.
Hands-on work to ensure corporate SOPs comply with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles.
Establishing compliance “knowledge base” that can be mined to extract compliance statistics and current regulations.
Review of marketing materials and other customer facing documents for regulatory compliance.
Oversight of Device Master Record and Device History Files.
Help in the Preparation and Coordination of Management Review Reports.
Review/audit of design transfer activities and document and record control.
Maintain international authorizations including ISO 13485:2016 Certification, MDSAP certification, MDD, MDR, and CMDCAS registrations, as well as the regulations that apply to any area the Company determines are in its best interest.
Other duties as assigned by supervisor
Minimum 5 years of demonstrated management and hands-on skills in key aspects of quality and regulatory compliance in the medical device industry.
Experience in understanding guidances from FDA and international regulatory agencies.
Strong verbal and written communications skills
Strong technical skills including comfort with use of office-based tools including those used for quality systems.
Ability and desire to continually expand knowledge on relevant domains
Role in the Quality Management System
Quality Planning (ISO 13485 Section 5.4.2), Management review (ISO 13485 Section 5.6) and Measurement, analysis and improvement (ISO 13485 Section 8 all sections).
Role in the Information Security Management System (ISMS)
· Principal official designated to assure the ISMS conforms to the requirements of ISO 27001. Designated position for reporting on the performance of the information security management system to executive management as part of Management Review.
The position requires up to 30% travel to company office locations and Client sites as needed for corporate and client site meetings.
Education / Certification Requirements
Bachelor’s degree in healthcare, IT, quality, or related field
Master’s degree in healthcare IT or similar graduate degree preferred
Auditor training for ISO 13485, ISO 27001
Risk Management training
Day to day work includes desk and personal computer work and interaction with Corporate, Business Unit Area and facility managers. The work environment is characteristic of an office and health care facility with air temperature control and moderate noise levels. With Supervisor’s authorization teleworking is allowed.
The physical demands are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Telecommuting is allowed.
Additional Salary Information: Benefits include medical, dental, vision, life insurance, PTO and 401k
Internal Number: 0001
AirStrip® makes transformational and lasting improvements in worldwide healthcare delivery by creating innovative technology for clinicians to collaborate and care for their patients. AirStrip provides a complete, vendor and data source-agnostic, enterprise-wide mobile interoperability platform that advances care collaboration and serves as a catalyst for health system innovation. With deep clinical expertise and strong roots in mobile technology and data integration, AirStrip is empowering leading health systems as the industry evolves at a rapid pace.