Job Description
As a Regulatory Affairs Associate, you will play a key role in supporting day-to-day regulatory activities and handling multiple projects related to regulatory compliance enhancements.
You will assist in the implementation of MDSAP within the organization, working closely with interdisciplinary team members to ensure the effectiveness of the Quality Management System (QMS) to regulations.
The ideal candidate will have excellent communication skills, be able to work independently, and have a strong understanding of regulatory requirements.
Required Skills & Qualifications
* Strong knowledge of regulatory requirements and compliance
* Excellent communication and interpersonal skills
* Ability to work independently and as part of a team
* Highly organized and detail-oriented
* Proficient in MS Office and other regulatory software
Benefits
This is an exciting opportunity for a motivated individual to join our team and contribute to the success of our organization. The successful candidate will receive a competitive salary and benefits package, including opportunities for career growth and professional development.
Other Responsibilities
Additional responsibilities may include:
1. Supporting the team to obtain/retain country-specific regulatory registrations on a global basis
2. Working with the Commercial Team/Distributors to ensure country-specific registration activities are understood and addressed
3. Coordinating investigations between complainants and contract manufacturing sites
4. Providing strategic regulatory insight to team members regarding product development plans