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Regulatory Affair Specialist

Regulatory Affair Specialist

randstad pte. limited
1-4 Years
SGD 3,500 - 4,200 per month
  • Posted 5 hours ago
  • Be among the first 10 applicants

Job Description

Regulatory Affair Specialist
1 year contract, potential to renew

Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing

FIND YOUR PLACE by joining a world-class MNC Healthcare company
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Company Description:
Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world's toughest health challenges, innovate through science and technology, and transform patient care.

Overall Purpose of the Role
The Regulatory Affairs Associate is a member of ASPAC Special Project. The incumbent is responsible for actively contributing to the regulatory compliance of medical devices. The incumbent is also responsible for data integrity and maintenance across multiple regulatory systems

Job Responsibilities

  1. The Regulatory Affairs Associate main responsibility is to support the ASPAC markets on MedTech regulatory affairs matters.
  2. Creation and maintenance of regulatory information in Regulatory Database system.
  3. Creation of routine reports to ASPAC markets related to regulatory compliance matters (submission schedules, eligibility and etc.).
  4. Creation of routine monthly Performance metrics report to ASPAC markets using basic IT skills
  5. Extended roles in providing administrative support to local Singapore Regulatory Affairs MedTech department, including RA database update, data analysis and local database maintenance.

Requirements

  • Bachelor's degree in related disciplines, Science or Engineering Field with minimum 1 year of experience
  • Good at Power BI, MS Word, MS Excel, MS Power Point
  • Has a strong sense of responsibility on meeting due/target and quality/integrity/accuracy of the output
  • The incumbent must have the ability to work effectively without supervision and process requests/work within required timeframes.
  • Strives to acquire a deeper understanding of medical and scientific and technological developments.
  • Views new and ambiguous challenges as a learning opportunity
  • Leadership Competencies: Assists and supports others in interactions with team members and internal stakeholders by partnering and collaborating with them effectively.
  • Familiarity with the regulatory systems and product registration requirements in Country
  • 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
  • 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

Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button. Alternatively, you can share your CV at [Confidential Information]

EA License: 94C3609
Reg No: R1440247

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