Regulatory Compliance Officer

Key responsibilities (analytical/decision making/supervisory):

• Implementing and managing an effective legal compliance program.
• Advising management on the company’s compliance with laws and regulations through detailed reports.
• Managing and ensuring timelines of various approval process such as product registration and product renewal to ensure compliance with regulations
• Creating and managing effective action plans in response to audit discoveries and compliance violations.
• Regularly auditing company procedures, practices, and documents to identify possible weaknesses or risk.
• Assessing company operations to determine compliance risk.
• Evaluating and filing of new products registration documents of medical devices to FDA in coordination with Foreign based Suppliers
• Ensuring all employees are educated on the latest regulations and processes.
• Resolving employee concerns about legal compliance.
• Responsible for ensuring that regulatory deliverables and activities are effectively executed to meet the business objectives.
• Overseeing that all company licenses to operate and product certificate of registrations are always maintained valid, achieving compliance and making uninterrupted business operations.
• Serving as a liaison between the company and the regulatory bodies
• Local Government Unit
• Food and Drug Administration
• Department of Health

QUALIFICATIONS:

Knowledge, skills and experience requirements: Describe what is required from the candidate to perform this role (technical, managerial or behavioral) and what is deemed mandatory or optional/considered as an asset.) Is flexibility of working hours required, is frequent travel involved)

• Good experience in process mapping and compliance roll outs
• Good knowledge of legal requirements and procedures
• Good communicator (written and oral); Letter and proposal drafting
• Able and successful negotiator

• Flexible (not picky with work, do what it takes attitude)
• Highly analytical with strong attention to detail
• Self-Starter and strategic (thinks ahead)
• Very intelligent and smart

• Hard work/ Puts in the time and expects that of others
• Fair and honest
• Wants a part of success and change in the Philippine health system
• Agile and flexible – willing to do whatever it takes to meet the company’s goals