The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
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.
As the head of the quality systems management team this position is responsible for quality systems, coordination of the documentation of administration of the information security management system, performance improvement, and national and international regulatory affairs strategy and implementation. The position scope includes the Company’s regulatory cleared medical software as a device and consumer software. Domestic and international settings including the US, Europe, Australia, Canada and South America, Asia, Russia, and China.
Essential Duties and Responsibilities
Establishment, Maintenance, Audit and Continuous improvements of the Company’s Quality Management System, Regulatory and other elective Compliance programs.
Overall leadership of Quality Assurance and Regulatory Affairs function
Working with Company executives, stategic alignment of QARA activities with evolving business needs
Proactive strategy for efficient compliance review of Company’s software
Software usability testing planning and risk management approach
Oversight of corrective and preventative actions (CAPAs)
Monoitoring and Analysis of the Company’s Compliance trends
Appropriate quality system review per FDA Quality System Regulations
Own strategy for regulatory and filing requirements of products
Own submission of regulatory filings to support Company marketing activities
Provide guidance on integration of partner clinical decision support algorithms into AirStrip solution suite (hardware and software) to maximize compliance
Ensure timeliness of internal audits and follow up on findings
This position is designated as the Management Representative under 21 CFR 820.20(b)(3) and is responsible for coordination of Management Review.
Ensuring ongoing, proactive compliance strategy for items listed above to include European Conformity (CE) requirements
This position is designated as the Person responsible for regulatory compliance (PRRC) under the EU regulations.
Therapeutic Goods Administration (TGA):
(Australia compliance): ensuring 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) ensuring proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in the Japanese and affiliated markets.
HIPAA / DIACAP/GDPR SECURITY:
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
Information Security Management System
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.
Cloud computing compliance (FEDRAMP, CE regulations, etc.) and ongoing determination of which ones apply and how to comply.
Coordination and effectiveness of Internal and external manufacturing inspections
Oversight and follow-up on Quality System issues and CAPAs
Determination, evaluation, coordination, and monitoring ongoing regulatory and consensus standards for the Company to comply with
Hands-on work as needed to ensure corporate SOPs comply with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles.
Advocacy and public speaking relating to safety regulations for clinical apps
Establishing compliance “knowledge base” that can be mined to extract compliance statistics and current regulations.
Establishing approach for effective review of marketing materials and other customer facing documents for regulatory compliance.
Oversight of Device Master Record and Device History Files.
Preparation and Coordination of Management Review Reports.
Responsible for Technical Files, Internal Audits, Risk Management, Document Control.
Auditing of design transfer activities and document and record control.
Product internationalization including ISO 13485:2016 Certification, MDSAP certification, MDD, MDR, and CMDCAS registrations, as well as the regulations that apply to any area marketing determines are in the Company’s best interest.
Other duties as assigned by Executive Management
Minimum 10 years of demonstrated leadership skills in quality and regulatory compliance in the medical device industry.
Experience with Software As a Medical Device and/or Software-Controlled Medical Devices strongly preferred
Experience in dealing with FDA and global regulatory agencies.
Strong verbal and written communications skills
Strong strategic, leadership, project and people management skills
Strong technical skills including comfort with use of office-based tools including those used for quality systems.
Role in the Quality Management System
Principle Quality and Regulatory Official and Management Representative (ISO 13485 Section 5.5.2), 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 or related field
Master’s degree in healthcare or other applicable graduate degree preferred
Lead Auditor Certification for ISO 13485, ISO 27001
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, HSA, PTO and 401k
Internal Number: 0002
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.