Job Overview
Regulatory Affairs Associate is responsible for coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under certain regulations.
Role and Responsibilities
- 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 NDR MedTech 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
Qualifications and Education Requirements
- Diploma or Bachelor degree or related scientific discipline with relevant regulatory experience in RA with experience in PMA/IDE submissions and direct FDA interactions
- 1-3 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 Type: Full-time
Pay: $1,800.00 - $4,000.00 per month
Work Location: In perso
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