Proximie is seeking an experienced Quality/Regulatory Affairs Manager to lead the development and execution of quality management and regulatory processes for Proximie products, as well as manage operational quality for outsource partners, field service and operations. The Quality/Regulatory Affairs Manager will work closely with multi-functional teams in Engineering, Product, Operations, as well as executive staff in leading quality reviews.
The QA/RA Manager leads and is responsible for ensuring that the Quality Management System (QMS) is effectively established and maintained throughout the organization. This person is also responsible for the development and execution of innovative regulatory strategies for Proximie’s products.
- Develops, implements and maintains processes and documentation for the quality management system in compliance with US FDA’s Quality System Regulation, the European Medical Device Regulation, ISO13485, and other relevant domestic and/or international regulatory requirements.
- Manages and oversees the QMS system and serves as an interface for external parties, such as regulatory bodies, external auditors, customers, governmental institutions, etc.
- Primary contact for interactions with the FDA and provides guidance and strategy for OUS regulatory filings.
- Develops regulatory strategies to ensure the most efficient FDA review pathway for regulatory submissions of Class 1 devices and software that function within the hospital operating room. Manages the preparation and submission of US FDA filings and regulatory documents.
- Along with internal and external partners, prepares global product submissions for Class 1 devices and software that function within the hospital operating room.
- Maintains awareness of regulatory landscape and ensures continued QMS compliance.
- Establishes the quality plan, including identifying QMS activities, schedules, and resources responsible or accountable for addressing QMS issues
- Establishes, implements and monitors training related to QMS processes, documentation and record control.
- Accountable for risk management process and activities, including post-production risk, to ensure all regulatory and compliance obligations are satisfied.
- Establish and maintain an effective CAPA program to ensure continuous improvement. Identifies and addresses gaps and areas of vulnerability in Proximie’s Quality Management System
- Maintain database for DMR, DHF, complaints, NCMR, RMA, Deviations, IQC and CAPA
- Reports to appointed management representative on the effectiveness of the quality management system and any need for improvement
- Works collaboratively with the Operations, Product, and Engineering teams
- Acts as a Regulatory and QMS Ambassador within Proximie, including conducting internal audits, auditing compliance with regulatory and other requirements, and monitoring the results of the process performance on a regular basis
- Perform duties in a manner that is consistent with and committed to upholding the requirements of the quality management system
- Perform other duties as assigned or required
- Bachelor’s degree in Engineering, life sciences, or a related field
- 5+ years of related QA/RA experience working in a medical device/equipment manufacturing industry. Direct CDRH experience required.
- 3+ years in a management position such as QA/RA manager/supervisory experience in a manufacturing environment improving quality systems and training employees
- Demonstrated knowledge and experience of quality systems and ability to sustain a strong Quality Management system
- Direct experience with Class I medical devices within the operating room environment
- Demonstrated knowledge of ISO 13485, ISO 14971, ISO 9001, 21CFR820 standards and regulations
- Completed training on current ISO 13485:2016 standard
- Certified ISO 13485 Internal Auditor
- Demonstrated experience drafting and submitting dossiers to regulatory bodies
- Experience managing FDA and notified body audits
- Experience with eQMS software considered an asset
- Excellent attention to detail, critical thinking and analytical abilities
- Demonstrated decision-making and problem-solving skills
- Demonstrates an uncanny ability to own and influence project and key results, executing flawlessly in a fast-paced, lean environment
- Excellent communication and interpersonal skills, with a demonstrated ability to influence, interact and work effectively with key internal and external stakeholders
- Ability to identify potential problems and take appropriate action
- Very strong time management and organizational skills with the ability to prioritize and manage own workload whilst multi-tasking in order to meet deadlines
- Must thrive in a start-up, fast-paced, ever-changing work environment and be comfortable navigating the “grey”