Regulatory Affairs

Work Schedule

Environmental Conditions

Job Description

Position summary

This is an outstanding opportunity to join Thermo Fisher Scientific Inc. in Shah Alam as a Regulatory Affairs professional. You will be at the forefront of ensuring our products meet the highest standards set by the Malaysian Medical Device Authority (MDA). Our team is high-reaching and dedicated to perfect compliance, making a world-class impact in the medical device industry!

Key responsibilities

• Provide daily support on product review and classification of medical devices in sales operations, known as 'Medical Device Screening'.
• Stay proficient and updated with Malaysia Medical Device Regulations, Orders, Circulars, and all GDPMD updates. Highlight implications of these updates to management, business units, and vendors.
• Maintain the Establishment License for FSM, taking proactive measures as necessary due to changes announced by MDA or the Malaysia Ministry of Health (MOH or equivalent experience).
• Manage Medical Device product registration in MDA e-portal for RSD, ensuring accurate documentation.
• Perform necessary amendments and resubmission of Medical Device registrations where applicable.
• Verify Medical Device product groupings and classifications, and follow up on payment statuses and registration statuses in the MDA e-portal.
• Collaborate with Regulatory Affairs personnel at Thermo Business Units and third-party vendors to acquire complete, accurate documentation as specified by MDA or equivalent experience.
• Facilitate submissions and approvals of Medical Device registrations with MDA officers.
• Evaluate the necessity of hiring external GDPMD consultants with the Product Management team.
• Provide detailed weekly update reports on Medical Device product registration progress to the Business Operations Manager.
• Offer monthly updates to management, Product Management Team, and Commercial Team on registration progress and raise concerns as needed.
• Lead and manage Site Quality Management systems, including QBR updates to the Corporate Quality Team.
• Prepare the site for government or regulatory audits and inspections.
• Ensure current and valid working procedures are recorded as Working Instructions (WI) according to CCG templates, and review WIs prepared by each workstream.
• Collaborate with RSD SG on shared processes, such as Global Trade Compliance (GTC) SOP.
• Prepare and conduct training related to Chemical Compliance Regulations.
• Support import permit applications (e.g., KKM Import Permit, Vet Import Permit, Psychotropic Substances Permit), serving as the primary contact for chemical compliance matters.
• Establish processes formally according to Chemical Compliance Regulations.

Other responsibilities

• Ensure written SOPs are in place and provide necessary samples of accurate documentation for Medical Device product registrations.
• Provide backup support to RSD SG as necessary.
• Complete successful Medical Device product registrations for GDPMD.
• Renew MDA certificates.
• Maintain Establishment License for Fisher Scientific (M) Sdn Bhd for GDPMD.
• Establish SOPs for future GDPMD registrations.
• Adhere strictly to all company policies and procedures.