Quality Assurance Regulatory Affairs Manager Job at Accordance Search Group, Houston, TX

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  • Accordance Search Group
  • Houston, TX

Job Description

Key Responsibilities:

  • Quality System Management, Cross-functional Collaboration, Regulatory Strategy, Team Management, Project Oversight, Compliance Audits and Inspections

Education & Experience:

  • Bachelor's in Biomedical, Mechanical, Industrial Engineering, or related field.
  • 7-10 years in medical device QMS roles, with experience in managing projects and teams.

Skills & Expertise:

  • Expertise in FDA QSR, ISO standards, MDSAP, EU MDR, and regulatory audits.
  • Medical Device Experience RAQA
  • Required FDA Class I, II
  • Required MDD Class IIa
  • Required MDR Ir, IIa
  • Exposure to Reprocessing, cleaning and sterilization
  • Exposure to in process validation for manufacturing
  • Exposure to EtO sterilization processes
  • Experience with DHF, Risk Management
  • General QMS:
  • Audit experience with FDA, notified bodies, internal audits
  • SOP Generation
  • Change control processes
  • Processes:
  • Must have complaint handling experience
  • Must have CAPA oversight experience
  • Experience with consolidation of company’s and processes
  • eQMS experience:
  • Ideally experience transitioning a team from paper to eQMS or ERP System

Strong Leader and Individual Contributor: Proven leadership experience with a focus on trust, accountability, and teamwork.

  • Leadership:
  • Will manage a staff of about 2-3:
  • SME for Registrations and Technical documentation
  • SME for Complaint Handling / Software Validation
  • Management style:
  • Mentor type to build and empower and challenge staff seeking growth
  • Able to handle conflict; Has hired and fired team members
  • Collaborative
  • Individual Contributor:
  • RA Rep on R&D Teams
  • Mindful of Quality Engineering
  • RA Rep Legacy change control
  • FDA limited 510k
  • Lead CAPA process
  • Support for software ERP/ annual processes
  • Identification for eQMS and lead implementation

Compensation flexible based on experience level

Open to Relocation candidates!

Job Tags

Relocation, Flexible hours,

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