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With over 400 committed consultants from various professional backgrounds and disciplines, we make a difference by delivering top-notch services to our clients and candidates alike.
EA License No. 99C4599
Regulatory Affairs Specialist (Regional Role) - Medical Device MNC
jobsDB Ref. JSG400003003030326
EA License No 99C4599
- Ensure all redressing activities are carried out in accordance with authorized specifications and that quality checks are performed throughout the process in a stringent and effective manner.
- Ensure all Quality Assurance (QA) operations and release activities are carried out in accordance to Good Manufacturing Practice (GMP) standards and established standard operating procedures.
- Act as advisor to principals and colleagues on regulatory matters in consultative and service-oriented manner.
- Manage the handling of controlled drugs in the appropriate manner and ensure at all times there is Pharmacist supervising these activities
- Manage the performance of the Quality Assurance & Regulatory team and provide appropriate guidance and development for each member to achieve their potential.
- Ensure QA Specialists are properly trained to carry out redressing quality checks and release and carry out GMP related training programme for the Company.
- Ensure general cleanliness and hygienic conditions of each workstation.
- Ensure compliance to ISO procedures, GMP and all regulatory requirements.
- Conduct internal audits, training and general communication to achieve and sustain a high level of quality performance throughout the organization so as to properly support the business and regulatory (ISO, GMP, GSDP) requirements in the most efficient manner.
- Work closely with inter-departmental personnel to ensure quality is maintained throughout the organization.
- Communicate with internal, external and regulatory stakeholders independently related to Operational Quality and regulatory matters.
- Participate in any adhoc projects as assigned by management from time to time.
- Min BSc/BA degree or Diploma holder in Life Sciences / Bioengineering / etc
- Min 1-2 years’ experience in preparing regulatory submissions, medical device documentation, reporting, and associated documents legalization is preferred, but not required.
- Previous work experience in life science products / medical device fields / pharmaceutical is preferred.
MNC (Medical Devices Organization)
Interested candidates, please forward your resume by clicking APPLY NOW!
Consultant: Huang Jingsheng Kevyn (R1333338)