Regulatory Affairs

Thermo Fisher Scientific; Kuala Selangor; On-site; MYR 35,000 - 60,000; Full time

Job summary

A leading company in the medical device industry seeks a Regulatory Affairs professional in Shah Alam. In this role, you will ensure compliance with Malaysian Medical Device Authority standards, manage product registrations, and support regulatory audits. This position offers a chance to impact industry standards significantly while working with a dedicated team.

Qualifications

• Understanding of Malaysian Medical Device Regulations.
• Experience in regulatory submissions and compliance.
• Ability to maintain licenses and documentation.

Responsibilities

• Provide daily support on product review and classification of medical devices.
• Manage Medical Device product registration in MDA e-portal.
• Conduct training related to Chemical Compliance Regulations.

Skills

Compliance

Regulatory Knowledge

Attention to Detail

Collaboration

Project Management

Education

Degree in Life Sciences or related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.