Job Responsibilities:Ensure regulatory compliance of company products and review documentation of medical device standards (MDA), European Union (CE), USA (FDA), and other regions.
Carry on product registration, system certification, renewal of certificates, and application for replacement of certificates according to the company's plan.
Follow up the registration and internal review of registration application information throughout the process and submit the application information to complete the registration application and supplementary application-related work.
Monitor the product registration progress, communicate with government and relevant industry departments on registration matters, coordinate and address problems in the registration process, and ensure timely acquisition of registration approval documents.
Stay updated on local medical device laws, regulations, standards, and guidelines.
Maintain and update regulatory files/databases for internal record keeping.
Participate in third-party/government or customer audits.
Requirements:Candidate must possess at least a Diploma/Advanced/Higher/Graduate Diploma in Biology, Biotechnology, Medical Science, or equivalent.
Hands-on regulatory experience in a manufacturing environment with ISO 13485 is preferred.
Experience in GMP, HACCP, and regulatory affairs matters related to medical device/disposable products.
Ability to work independently and under pressure.
Responsible, attentive to detail, and caring.
On-the-job training will be provided.
Perks and Benefits:Medical Benefits
Seniority Reward
Year-end salary adjustment
Year-End Bonus
Miscellaneous allowance
Parking
Annual Salary Increment
Company Overview:
Vital Healthcare has been present in Malaysia since 2014, with a state-of-the-art factory in Port Klang, Selangor.
We are dedicated to supplying high-quality medical devices for blood purification to customers worldwide.
Our products include blood tubing sets, dialyzers, hemodialysis bicarbonate, and disposable arteriovenous fistula needle sets.
We prioritize product quality to ensure the best experience for users throughout hemodialysis procedures.
Our commitment to quality is driven by continuous technological innovations and diligent inspections prior to delivery.
We invite aspirants to join us in creating a glorious future at Vital Healthcare.#J-18808-Ljbffr