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Project/Program Manager - Non IT- Level 3
Ref No.: 18-14402
Location: San Diego, California
Position Type:Contract

Project/Program Manager
San Diego, CA
One Year Contract
Must have Regulatory Affairs or QA backgrounds.
This position is responsible for overseeing all deliverables to ensure the site is ready for the new IVDR directive. This candidate will be coordinating with cross-functional teams, including but not limited to Marketing, Operations, Quality, Regulatory and Supply Chain to ensure that all deliverables are completed correctly and delivered on time.

Tasks and responsibilities:
• Develop necessary project plans locally and manage reporting on project progress and achievement of key milestones.
• Oversee project to make necessary updates to Quality System requirements across all functional areas to align to new requirements in IVDR directive.
• Experience writing Standard Operating Procedures and upgrading Quality Systems to align to new requirements.
• Knowledgeable of regulatory requirements, e.g. QSR's, ISO 13485, FDA GMP & 820 regulations, IVDR directive in EU.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Perform other duties & projects as assigned.

Preferred Educational Background:
Bachelor's Degree in related field
Minimum 5 years' experience in Quality or Operations within the healthcare or biotechnology industry
Extensive experience leading projects to completion.
Demonstrate ability to effectively and constructively communicate across departmental disciplines while pursuing project goals
Proven ability to provide sound conclusions and recommendations
Understanding of new IVDR requirements
Understanding of ISO 13485 and FDA, EU requirements
Strong communication and leadership skills
Demonstrate organizational skills with a focus on detailed work
Ability to initiate and manage multiple tasks in a fast-paced environment
Must be able to work as part of a team, meet deadlines & take instruction from multiple persons