Regulatory Compliance Manager
hace 16 horas
Company Overview
We are a health technology company dedicated to making a positive impact on people's lives. Our mission is to provide innovative solutions that improve healthcare outcomes and enhance the quality of life for patients around the world.
Job Description
The Regulatory Compliance Manager will play a critical role in ensuring that our products comply with all relevant safety and environmental policies and regulations. This includes implementing requirements, conditions, and enablers within the business and site.
Responsibilities:
- Manage a team of supervisors, complaint investigators, and inspection teams (Receiving, in-process, and final inspections).
- Monitor daily work operations and provide direction and guidance to team members and/or project teams.
- Support new product development and/or design changes in coordination with management, project leaders, and project teams.
- Oversee, own, review, and approve procedures and work instructions, nonconformances, complaint investigations, inspection records, and CAPAs, as applicable.
Key Objectives:
- Ensure that products, materials, and components are reviewed, tested, inspected, recorded, qualified, and released in accordance with regulatory requirements.
- Investigate complaints in a timely manner and in accordance with regulations and Philips procedures.
- Provide training to the team and manufacturing as needed.
- Participate in audits with regulators, agencies, and auditors, such as FDA, competent authorities, and notified bodies.
- Support post-market surveillance and recall activities as needed.
- Lead succession planning and development planning for the team.
Requirements:
Advanced English language skills are required. A bachelor's or master's degree is mandatory, with Engineering or Science preferred. Typically, a minimum of 8+ years of experience in the FDA regulatory industry is required (Medical Devices, Pharmaceutical, or combination thereof). CQE, CBA, or CQA certifications are preferred. The successful candidate must have demonstrated ability to work with senior leaders and engage/influence cross-functional leadership teams. On-site presence is necessary.
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