Job Description

Job Summary:

We are seeking a detail-oriented and proactive Regulatory Affairs Executive to join our team. The successful candidate will be responsible for product registration activities, technical file preparation and the management of product complaints, ensuring compliance with local and international regulatory requirements (MDA, ISO 13485:2016, GDPMD, CE MDR, FDA).

Job Responsibilities:

Prepare, submit, and track regulatory submissions for new and existing products in accordance with MDA regulations. Prepare technical file in accordance to CE MDR regulations. Maintain up-to-date knowledge of regulatory requirements and communicate changes to internal stakeholders. Collaborate with cross-functional teams to gather required documentation and ensure timely submissions. Manage product labelling, instructions for use (IFU), and marketing materials to ensure compliance. Receive, investigate, and document product complaints in compliance with internal procedures and regulatory standards. Ensure timely communication of complaint investigation results to customers and regulatory bodies as required. Participate in post-market surveillance activities and assist with product recalls when necessary. Participate in external and internal audits.

Qualifications:

Bachelor's degree in Life Sciences, Biomedical Engineering, or a related field. Minimum of 1 year of experience in regulatory affairs within the medical device industry. Familiarity with global regulatory standards (e.g., EU MDR, ISO 13485, FDA, MDSAP). Strong organizational skills with attention to detail and accuracy. Excellent communication and interpersonal skills. Proficiency in Microsoft Office Suite.

Location:

Bukit Kemuning, Batu 6, Shah Alam, Selangor.
Job Types: Full-time, Permanent

Pay: RM2,500.00 - RM3,500.00 per month

Benefits:

Health insurance Maternity leave Opportunities for promotion Parental leave
Work Location: In person