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Senior Regulatory Affairs Professional

1 month ago

Singapore BIOBOT SURGICAL PTE. LTD. Full time
About BIOBOT SURGICAL PTE. LTD.

We are a leading medical device company committed to providing innovative solutions for the healthcare industry.

Job Title: Senior Regulatory Affairs ExecutiveSalary: SGD 120,000 - SGD 180,000 per annumAbout the Role:

We are seeking an experienced Senior Regulatory Affairs Executive to join our team in Singapore. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with domestic and international regulations and standards for our medical devices.

The ideal candidate will have a strong background in medical device regulatory affairs, experience in FDA 510(k) or CE marking, and knowledge of relevant regulatory guidelines and standards such as ISO 13485 and EU MDR 2017/745.

Key Responsibilities:
  • Drafting, compiling, and maintaining technical documents to ensure compliance with applicable regulations and standards;
  • Preparing and submitting regulatory technical documentations to regulatory authorities for new registrations, renewals, and change notifications;
  • Ensuring compliance with applicable regulatory requirements and standards for medical devices;
  • Working closely with internal teams for documentation and information gathering;
  • Liaising with regulatory authorities and authorized representatives on requirements needed to facilitate product approval and address any deficiencies and queries;
  • SUPPORTING adverse event reporting, reporting adverse events to regulatory authorities in relevant countries within stipulated timelines when required;
  • Participating in internal/external audits as part of the audit team (including supplier audits);
  • Maintaining up-to-date knowledge of regulatory requirements and changes;
  • Ensuring post-market surveillance obligations are complied with regulations;
Qualifications and Experience:
  • Bachelor's degree in biological science, biological engineering, pharmacy, or related field;
  • 4-5 years of experience in medical device regulatory affairs with experience in FDA 510(k) or CE marking;
  • Familiarity with relevant regulatory guidelines and standards such as ISO 13485, EU MDR 2017/745;
  • Strong attention to detail and organization skills;
  • Ability to work independently and as part of a team;
  • Strong problem-solving and analytical skills;
  • Excellent written and verbal communication skills;
About Us:

BIOBOT SURGICAL PTE. LTD. is a dynamic and innovative company that provides cutting-edge medical devices to the healthcare industry. We offer a competitive salary package and opportunities for professional growth and development.