Medical Device Regulatory Affairs Officer
3 days ago
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
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