Quality Assurance Regulatory Affairs Manager. Job in Sunnyvale WestCoast-Jobs

  • Job Reference: 462851647-2
  • Date Posted: 2 January 2022
  • Recruiter: Charlton Morris
  • Location: Sunnyvale, California
  • Salary: On Application
  • Sector: Government & Defence
  • Job Type: Permanent

Job Description

Charlton Morris (CM) Medical is currently partnered with a really exciting global manufacturer in the Spinal sector of Medical Devices. With global growth & huge plans for innovation, the company are seeking a new leader for Quality Assurance & Regulatory Affairs


This is a unique technical role with a high impact. Leading a team & consistent direct communication with executive leadership are key responsibilities in a position that will lead compliance initiatives worldwide. The company has aN SME culture, promoting internal growth & autonomous working while providing strong funding & benefits structures.


Responsibilities

  • Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA's Quality System Regulation, the European Medical Device Directive, ISO13485, and other relevant domestic and/or international regulatory requirements.
  • Leads a team of QA/Regulatory Compliance professionals.
  • Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements.
  • Monitors completion of Post-Market activities, including complaint handling, to verify satisfaction of regulatory requirements, and manages or supports Recalls and Field Removals.
  • Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures.
  • Maintains CAPA process and verifies CAPA's are implemented as required to maintain suitability of both products and the Quality System.
  • Maintains awareness of regulatory landscape and takes appropriate steps to ensure continued QMS compliance.


Requirements

  • 5+ years experience in the medical devices sector, with at least 6 years related to quality systems and/or regulatory compliance.
  • Experience in post-market surveillance activities is highly desirable.
  • Knowledge of national & international quality systems, regulations & standards including 21CFR Part 820, ISO 13485:2016, ISO 14971, and ISO 11135.
  • Bachelor's degree in an engineering or science field (preferably engineering).
  • Class III medical device experience