In this role, you have the opportunity to
Be responsible for managing regulatory compliance and quality programs at Philips Puerto Rico / North Latam. This role provides regulatory direction to the business regarding regulatory requirements for product launch, submissions and post-market compliance.
This includes activities focused on quality systems, product safety, post-market surveillance, risk management, field corrections, CAPAs and inspection readiness.
This position will also provide project management support for quality and regulatory compliance projects and initiatives.
You understand that collaborative, cross-functional teams are the most effective, and your communication skills successfully bring these diverse groups together to spawn creative, open-minded and out-of-the-box thinking.
You are responsible for
Manage Daily Management of critical KPIs and leading indicators related to complaining handling, FCO management / implementation, and escalation trending for example.
Understands and applies regulatory requirements and their impacts in reviewing licensing submissions when applicable
Supports quality and regulatory inspections as required (Philips or FDA)
Supports and encourages a collaborative, open and team-based culture across the organization and the larger Q&R organization
Demonstrate knowledge of Health FDA and Latam regulatory and quality requirements and utilizes depth and breadth of experience to assess regulatory changes, risk, and business impact.
Oversee the product hold in alignment with Corporate policies and procedures.
Apply thought leadership and foster a culture of continuous improvement by identifying areas to improve, driving continuous improvement initiatives and utilizing problem-solving methodologies to enhance business performance.
Provide ongoing guidance and direction to operations and other business functions regarding regulatory and quality matters.
Responsible to assist in the assessment / confirmation that an adverse event (MDR, Vigilance, MPR) has occurred and then to report to the appropriate agency and / or the authorized representative.
Assist with Field Actions this may include developing the field action strategy, initiation, communication / notification, monitoring / updates, reporting to FDA and closure of the action when applicable.
Ensure Philips Medical Device Establishment License (Device Initial Importer) is maintained in good standing with Health USA (FDA).
Review and approve local marketing communications for compliance to local regulations
Manage and improve the handshake process within business clusters and local marketing to ensure a successful and timely premarket approval
To succeed in this role, you should have the following skills and experience
Minimum of 4-year experience working in a Quality and Regulatory role in the medical device industry
Applied comprehensive knowledge of FDA and Latam regulation.
Willingness to challenge existing systems / practices in order to improve them.
Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to work effectively with internal and external stakeholders.
In return, we offer you
A competitive environment that fosters team collaboration, cross-functional problem solving focused on end-to-end processes.
This position brings high visibility by working closely with Q&R and Business leaders across the organization to deliver results.
In addition, this position will allow you to learn all aspects of the Service organization and build in-depth knowledge of the end-to-end process for complaint handling, field actions, and escalation management.