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Regulatory Affairs Specialist
2 months ago
Abbott is a prominent global healthcare organization dedicated to enhancing health and well-being across all life stages. Our extensive portfolio includes transformative technologies that span diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000, we serve individuals in over 160 countries.
Position Overview:
As a leader in Cardiac Rhythm Technologies, Abbott is committed to pioneering innovations that improve the treatment of heart arrhythmias. The Regulatory Affairs Coordinator will play a crucial role at our Sylmar, CA facility within the Cardiac Rhythm Management Division, providing essential administrative support for regulatory functions.
Key Responsibilities:
- Ensure adherence to Corporate and Divisional Policies and procedures.
- Strategic Planning:
- Implement global regulatory assessments and manage product release authorizations.
- Identify and execute enhancements to regulatory processes.
- Collaborate across departments to gather necessary inputs for regulatory activities.
- Maintain Standard Operating Procedures (SOPs) and related documentation.
- Keep updated records on relevant legislation, regulations, and guidelines.
- Assist in tracking and reporting project timelines.
- Premarket Activities:
- Facilitate global regulatory assessments to inform regulatory strategies.
- Support the market release of products.
- Organize materials for presubmission reports and prepare submission packages.
- Compile and review documentation from preclinical and clinical studies.
- Postmarket Responsibilities:
- Maintain and update regulatory files and archival systems.
- Prepare routine reports and communications for regulatory agencies.
- Assist with internal audits and inspections.
- Prepare postmarket reports and submissions.
- Update global product listings and maintain facility registrations.
Qualifications:
- High school diploma required.
- Strong verbal and written communication skills.
- Ability to collaborate effectively with departmental teams.
- Understanding of business and regulatory ethical standards.
- Attention to detail and ability to meet deadlines.
- Research skills to locate regulatory information.
Preferred Qualifications:
- Associate's or Bachelor's degree in a relevant technical field (e.g., biology, chemistry, engineering).
- Experience in a regulated industry.
Benefits:
Abbott offers a comprehensive benefits package, including free medical coverage for employees, a robust retirement savings plan, and educational assistance programs. We are recognized globally as a top employer and a leader in diversity and inclusion.
Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce.
