Senior Regulatory Affairs Specialist / East Area

Company Overview Our client is a global Medical device manufacturer providing healthcare regulatory consultancy across Asia. Due to their current expansion plan, they are looking for a Senior Regulatory Affairs Specialist to join their team, in hopes of developing the current high performing team. They are located in the East area. Job Responsibilities Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications Prepare and submit regulatory filings, including 510(k) submissions, IDEs, and PMA applications Develop and maintain relationships with regulatory agencies, including FDA, MHLW, and other international authorities Ensure compliance with relevant regulations, such as FDA's Good Manufacturing Practice (GMP), ISO 13485, and EU's Medical Device Regulation (MDR) Collaborate with cross-functional teams to develop and implement regulatory strategies for new products and product lines Provide expert guidance on regulatory requirements and ensure that all necessary documentation is prepared and submitted in a timely manner. They are looking for someone who has experience in the medical device industry, preferably in Regulatory Affairs, and has knowledge of FDA regulations.