Job Description

We\'re hiring for MNC Company!

Position : Regulatory Affairs Specialist

Work Location: Sunway Pinnacle Office

Working Days/Hours: Monday - Friday, Normal working hour

Contract Duration: 12 months contract with PERSOLKELLY (possible to renew contract if performance is good)

Salary: Between RM3500 - 4500 + completion bonus with statutory contribution

Training : To be provided once onboarded

Requirements :

• A bachelor\'s degree, preferably in Biomedical Engineering, Pharmacy, Life Science or any related discipline;

• 1-2 years\' experience in regulatory affairs;

• Familiarity with the regulatory systems and product registration requirements in Malaysia;

• Previous experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and or Registration dossiers);

• Excellent verbal and written communication skills - proficiency in written and oral English is required;

• Ability to interpret complex issues and present them in simple terms to facilitate understanding by others;

• Demonstrated ability to handle multiple projects;

• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;

• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required;

• Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.

• Proactive team player, able to take charge and follow-through.

Working Experience (Years): 1-2 years\' experience in regulatory affairs.

Qualifications: A bachelor\'s degree, preferably in Biomedical Engineering, Pharmacy, Life Science or any related discipline

Responsibilities :

1. The Regulatory Affairs Specialist will be a member of the local Regulatory Affairs Medical Devices department within company, with responsibility for regulatory aspects of the assigned product portfolios or Projects.

2. Conduct impact assessments due to EU MDR and Base Business changes.

3. Preparation of dossiers and on-time submissions to the local health authority for EU MDR and Base Business lifecycle management activities in accordance with Marketing launch plans and global timelines.

4. Maintain internal and source company databases of regulatory approvals

5. Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Malaysia and request the documentation required for registration submissions

6. Liaise and establish cooperative relationships with cross function teams (eg. Commercial, supply chain, quality etc) to ensure smooth transition of products from EU MDD to EU MDR.

7. Build constructive relationships with the local health authority by compiling and submitting required documents and providing responses to questions via return applications

8. Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio

9. Contribute to continuous review and improvement of processes within the Malaysia Regulatory Affairs department to ensure consistent, efficient and effective practices across the team

10. Contribute to Regulatory Affairs Team meetings to learn from colleagues, share experiences and best practice

11. Assist Regulatory Affairs colleagues in supporting other product portfolios or regulatory activities, as required

Serious applicants may send your resume to

Reference Number:

Contact Details:

Nursabrina_Zaidi@persolkelly.com

Profession:

Healthcare & Pharmaceutical
Medical Research

Company:

PERSOLKELLY_RHQ

Date Posted:

9/03/2023 9:40:00 PM

PersolKelly