Regulatory Affairs Operations Coordinator II
2 weeks ago
Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive portfolio includes innovative technologies across diagnostics, medical devices, nutrition, and branded generic medicines.
With a workforce of 114,000 employees, we are committed to serving communities in over 160 countries.
Position Summary:
We are seeking a Regulatory Affairs Operations Specialist II to join our team. This role is essential in ensuring that our products meet the necessary regulatory standards for global market entry.
Key Responsibilities:
- Facilitate product releases by preparing Global Trade Services (GTS) licenses for various products and regions.
- Adhere to standard operating procedures (SOPs) for managing GTS licenses and regulatory operations.
- Provide guidance on regulatory compliance and review GTS blocked orders.
- Monitor customer service requests and maintain effective communication with stakeholders.
- Collaborate with cross-functional teams to support product launches and modifications.
- Ensure compliance with FDA regulations and international guidelines.
Qualifications:
To be considered for this role, candidates should possess a Bachelor's Degree or equivalent experience, along with 2-3 years in a regulated industry. Knowledge of regulatory guidelines and strong communication skills are essential.
Preferred Qualifications:
A degree in a scientific or technical field is advantageous, as is experience in the medical device sector. Certification in regulatory affairs is a plus.
Why Join Abbott?
At Abbott, you will have the opportunity to grow your career in a supportive environment that values diversity and inclusion. We offer competitive benefits, including comprehensive health coverage and retirement plans.
Join us in our mission to improve lives through innovative healthcare solutions.
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