Job Summary:

The primary responsibility of this job role is to handle various aspects of medical device regulations including product registration submission and liaising with competent authorities on regulatory matters. This role will be the focal point of contact for marketing and manufacturer for all regulatory activities, also working closely with RA affiliates and distributors to drive regulatory activities in countries within the region. 

Duties & Responsibilities:

• Evaluate regulatory risks of Medical Business division policies, processes, procedures.
• Develop new regulatory policies, processes and SOPs in Medical Business and train key personnel.
• Prepare and maintain technical documentation packages to ensure regulatory requirements for product registration submissions to competent authorities are met in regional countries.
• Update, renew and maintain document control system, including registration documents, files, records of new and existing product portfolio.
• Monitor impact of changing regulations and update internal stakeholders.
• Oversee processes involved with maintaining annual licenses, registrations, listings and import/export controls.
• Review and approve advertising and promotional items to ensure regulatory compliance and ensure external communications meet regulations in Medical Business.
• Provide regulatory input for product recalls and recall communications.
• Coordinate and implement quality system standards required.
• Responsible for proper documentation of internal and external audits.
• Assist management in the implementation and maintaining of regulatory system; legal and compliance issues pertaining to quality management system.
• Compile all regulatory data and framework to educate relevant / related stakeholders.
• Other duties and projects, as assigned.

• Thorough knowledge of medical device regulatory framework
• Hands on experience in product registration submission and dealing with competent authorities.
• Meticulous, good organization/planning and negotiation skills.
• Excellent verbal and written communication skills.
• Positive attitude and able to work well as team player.
• At least 2 - 3 years of relevant regulatory affairs experience in medical device.

HumanGo Consulting Asia Limited is a recruitment consultancy company. We are highly committed to improving the efficiency of talent sourcing.

To stay competitive in business today, organizations must drive to access to high-performing and skillful talents to adapt to an ever-changing market.

Recruitment is an evolving human resources process. It is crucial to have specialized consultants to offer professional guidance and advice throughout the job hunting process.