Regulatory Affairs Coordinator

1 day ago

Taguig, National Capital Region, Philippines B. Braun Medical Supplies, Inc. Full time $40,000 - $80,000 per year

POSITION SUMMARY 

The Coordinator, Regulatory Affairs plays a crucial role in supporting regulatory compliance efforts and facilitating the efficient management of regulatory activities. The incumbent will assist with regulatory submissions, track regulatory documents, and support regulatory compliance initiatives. This role requires strong organizational skills, attention to detail, and the ability to work effectively in a dynamic and fast-paced environment. 

MAJOR ACTIVITIES AND RESPONSIBILITIES

Assist with the coordination and preparation of regulatory submissions, including applications, notifications, registrations, and reports to regulatory agencies.

Ensure timely and accurate completion of regulatory submissions by coordinating document collection, review, and assembly.

Track submission timelines, milestones, and deliverables to ensure compliance with regulatory requirements and internal deadlines.

Maintain regulatory documentation and records, including regulatory files, correspondence, approvals, and certificates. Organize and manage regulatory documents and data in electronic systems or document repositories.

Ensure the accuracy, completeness, and accessibility of regulatory documentation for internal and external stakeholders.

Support regulatory compliance activities, including monitoring changes in regulations, assessing compliance risks, and implementing compliance measures.

Assist with regulatory audits, inspections, and assessments by preparing documentation, coordinating responses, and addressing findings as needed.

Provide administrative support to regulatory affairs team members, including scheduling meetings, preparing agendas, and documenting meeting minutes.

Assist with product registration and approval activities by coordinating document collection, review, and submission. Communicate with internal stakeholders to gather necessary information and documentation for regulatory submissions.

Track and report on regulatory status, milestones, and timelines for product registrations and approvals. Collaborate with cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, Manufacturing, and Marketing, to support regulatory requirements for product development and commercialization.

Serve as a liaison between regulatory affairs and other departments to facilitate communication, information sharing, and coordination of regulatory activities.

Participate in project teams, meetings, and initiatives to support regulatory compliance and achieve organizational goals and objectives.

This job description covers the main tasks and conveys the spirit of the sort of tasks that are anticipated proactively. Other tasks may be assigned as necessary according to organizational needs 

REQUIREMENTS

Bachelor's degree in Pharmacy  or healthcare-related field preferred.

Minimum of 1-2 years of experience in regulatory affairs, quality assurance, or related field in the healthcare or medical device industry.Knowledge of regulatory requirements and guidelines, including FDA regulations, EU MDR, ISO standards, and international regulatory requirements preferred.Strong organizational, communication, and interpersonal skills with the ability to manage multiple tasks and priorities effectively.

Proficiency in Microsoft Office Suite and ability to learn and navigate regulatory affairs software and electronic document management systems.

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