Regulatory Affairs Officer

2 weeks ago

Queenstown, Singapore NDR MEDICAL TECHNOLOGY PRIVATE LIMITED Full time

**Main Job Responsibilities**
- Provide medical review and assure compliance of medical product in accordance with approved labeling, applicable regulations and industry standards.
- Plans and prepares regulatory documents for new product registrations.
- Effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets.
- Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
- Maintains professional relationships with functional areas outside regulatory.
- Acts as company liaison with CE, FDA, HSA and other Regulatory Agencies.
- Conduct internal and external audits to ensure appropriate ongoing Company-wide regulatory compliance with applicable GMP/ISO/EN standards and other pertinent standards.
- Reviews proposed labeling and promotional material to ensure that the intended use and claims are supported for use and domestic and international regulations are met.
- Provides strategic direction and advice to project team regarding regulatory pathways and timelines for new and changed products/processes.
- Establishes, organizes and maintains regulatory records.
- Obtains and manages foreign registrations partner with appropriate representatives to locally confirm and file foreign regulatory requirements.
- Ensures compliance with global regulations and regulatory agencies.
- Maintains familiarity with current medical literature and surgical techniques in the field.
- Supports the development and implementation of regulatory strategies throughout the product life cycle including product development, labeling, promotional materials and regulatory evaluation of changes
- Performs additional duties as assigned.

**Education and Experience**
- Degree in any science related field, fresh graduate is welcome to apply.
- Minimum 2 years of experience in CE and FDA regulatory affairs would have an advantage
- Familiar with regulatory affairs such as internal and external audits, NDA, variation and renewal of product registrations in medical device industry (manufacturer or distribut

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

**Salary**: $3,000.00 - $4,500.00 per month

**Benefits**:

- Dental insurance
- Flexible schedule
- Professional development
- Work from home

Schedule:

- Monday to Friday

Supplemental pay types:

- Performance bonus

**Education**:

- Bachelor's or equivalent (preferred)

Willingness to travel:

- 25% (preferred)

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