Senior Regulatory Affairs Specialist (Medical Devices) | Up to $6,000 | Mon–Fri Office Hours

MCI CAREER SERVICES PTE. LTD.

Singapore, Singapore
Up to $6,000; not specified; annual leave starting...
Not specified (assumed to be in-office based on job description context).
Us fda 510(k) submission experience
Eu mdr technical file preparation
Global regulatory filing management
MCI Career Services Pte. Ltd. is seeking a Senior Regulatory Affairs Specialist for the medical devices sector in Singapore, offering a salary of up to $6,000 and stable office hours from Monday to Friday. The role involves regulatory strategy, submission preparation, and compliance management for medical devices, with a focus on US FDA and EU regulatory requirements

Job Summary

  • The role involves providing regulatory strategy and guidance to product development teams for strategic planning and pre-marketing activities.
  • Candidates will be responsible for preparing and maintaining regulatory filings including US FDA 510(k) submissions and EU Technical Files.
  • The position offers an attractive salary package of up to $6,000 with stable Monday to Friday office hours.

Matching Summary

Match Score: 85

MCI Career Services Pte. Ltd. is seeking a Senior Regulatory Affairs Specialist for the medical devices sector in Singapore, offering a salary of up to $6,000 and stable office hours from Monday to Friday. The role involves regulatory strategy, submission preparation, and compliance management for medical devices, with a focus on US FDA and EU regulatory requirements.

Salary

Up to $6,000; Not specified; Annual leave starting from 14 days

Skills & Requirements

Must-have

  • US FDA 510(k) submission experience
  • EU MDR Technical File preparation
  • Global regulatory filing management
  • Vigilance and MDR reporting knowledge
  • Field Safety Corrective Action support

Nice-to-have

  • Strong communication with authorities
  • Experience in endoscopy industry
  • Proactive gap analysis skills
  • Database management capabilities

Key Requirements

  • Experience in medical device compliance
  • Knowledge of US FDA regulations
  • Familiarity with EU MDR requirements

Work Rights

Not specified

Tailored Resume

Cover Letter