Regulatory Affairs Executive - Medical Device

Company Description Recove Group Sdn Bhd (Recove) is a Malaysian-owned, technology-based company founded in December 2016 with a focus on delivering innovative products and services. The company began with engineering and project management consulting and has since shifted toward developing its own innovative products in collaboration with reputable research and development centers. Recove aims to create solutions that simplify daily life and optimize time and value for customers. Built on strong engineering expertise and proprietary technology, Recove is working toward establishing its own brand of products with support from Malaysia's government technology development centers. The organization offers opportunities to contribute to impactful, technology-driven solutions in a growing and dynamic environment.

Role Description The Regulatory Affairs Executive – Medical Device is a full-time, on-site role based in Bandar Baru Bangi. This role is responsible for preparing, reviewing, and maintaining regulatory documentation and technical files for medical devices, ensuring accuracy and alignment with local and international standards. The executive will coordinate dossier preparation and submissions, track approval timelines, and liaise with regulatory authorities and notified bodies. Daily tasks include monitoring regulatory requirements and changes, advising internal teams on compliance implications, and supporting product development and labeling to meet regulatory guidelines. The role also involves maintaining orderly records, supporting audits and inspections, and collaborating with cross-functional teams to ensure continuous regulatory compliance throughout the product lifecycle.

Qualifications

• Strong foundation in Regulatory Affairs, with experience in medical device regulations and registration processes.
• Proficiency in Regulatory Documentation and Dossier Preparation, including creating, organizing, and updating technical files and submission packages.
• Knowledge of Regulatory Requirements and Regulatory Compliance, including awareness of relevant Malaysian and international standards and guidelines.
• Bachelor's degree in a relevant field such as Biomedical Engineering, Health Sciences, Pharmacy, or related discipline.
• Attention to detail, strong organizational skills, and the ability to manage multiple projects and deadlines.
• Effective written and verbal communication skills, with the ability to present regulatory information clearly to internal and external stakeholders.
• Ability to work collaboratively with engineering, quality, and commercial teams, and to engage professionally with regulatory authorities.
• Prior experience in medical device regulatory affairs or quality assurance is an advantage.

Work Location: Bangi

Salary Range: RM3,000.00 RM4,000.00

2 3 years experience