Quality Assurance Regulatory Affairs Manager

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!