Medical Device Regulatory Affairs Officer

5 days ago

Singapore NDR Medical Technology Pte Ltd Full time

Job Description
- Develop and execute regulatory plans for complex projects including new products and maintenance of existing marketing authorizations
- Represent or lead the RA function on assigned cross-functional project teams
- Monitor applicable regulatory requirements; assure compliance with NDRMedTech and external standards
- Establish appropriate communication within RA and other functions primarily at project level
- Perform gap analysis and propose solutions
- Develop and document sound regulatory decisions and justifications
- Ensure project teams and business objectives and deliverable are aligned with regulatory strategy
- May review promotional material or SOPs for compliance with local and global regulations
- Any other tasks assigned by supervisor
Job Requirement
- Bachelor degree or country equivalent in related scientific discipline with relevant regulatory experience in RA with experience in PMA/IDE submissions and direct FDA interactions
- 2-3 years working experiences in relevant field
- Basis of Regulatory knowledge
- Scientific Knowledge
- Ability to manage complex projects and timelines
- Strong oral and written communication and presentation skills
- Good interpersonal skills
- Ability to independently identify compliance risks and escalate when necessary
- Preferably with experience in medical device development.

**Job Types**: Full-time, Permanent

**Salary**: $2,500.00 - $4,000.00 per month

Schedule:

- Monday to Friday
Work Remotely:

- Temporarily due to COVID-19

  • Medical Device Regulatory Affairs Intern

    2 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Company Alcotech Pte Ltd Designation Medical Device Regulatory Affairs Intern Date Listed 18 Jul 2025 Job Type Entry Level / Junior Executive Intern/TS Job Period From Aug 2025, For At Least 6 Months Profession Healthcare / Pharmaceutical / Sports Industry Healthcare / Fitness / Sports Location Name Bukit Batok, Singapore ...

  • Regulatory Affairs Specialist

    7 days ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    **THE OPPORTUNITY**: An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market...

  • Junior Regulatory Affairs Specialist

    2 weeks ago

    Singapore Andaman Medical Full time

    We are looking for a Regulatory Affairs Specialist with at least 1 year experience in medical devices and or any related field, who can further assist our team in Thailand in processing medical device registration, determining risk classifications of health products and monitoring trends regarding the industry regulations. - Preparing and submitting...

  • Senior Regulatory Affairs Specialist, Apac

    7 days ago

    Singapore Zoll Medical Corporation Full time

    Resuscitation Job Summary: This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance. At ZOLL, we're passionate about improving...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health...

  • Regulatory Affairs Specialist

    3 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore ALCOTECH PTE. LTD. Full time $49,300 - $63,500 per year

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    **Alcotech Pte Ltd**specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. **Role Overview**: **Key Responsibilities**: - Prepare, review, and submit medical device registration dossiers...

  • Regulatory Affairs Specialist

    4 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Roles & ResponsibilitiesAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at...

  • Regulatory Affairs Specialist

    3 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Roles & ResponsibilitiesAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at...