Regulatory Affairs Specialist
2 weeks ago
Abbott is a leading global healthcare organization dedicated to enhancing health outcomes across various life stages. Our diverse portfolio includes innovative technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve individuals in over 160 countries.
Working at Abbott
At Abbott, you will engage in meaningful work, experience personal and professional growth, and enjoy a supportive environment that values your individuality and well-being.
Benefits:
- Career advancement opportunities within a global organization.
- Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
- Robust retirement savings plan with significant employer contributions.
- Tuition reimbursement and programs to assist with student debt.
- A workplace recognized for its commitment to diversity and inclusion.
Position Overview
As a key player in the Cardiac Rhythm Management Division, the Regulatory Affairs Coordinator will be based at our Sylmar, CA facility. This role involves providing essential administrative support for regulatory processes and compliance.
Key Responsibilities:
- Ensure adherence to Corporate and Divisional policies and procedures.
- Execute global regulatory assessments and manage product release authorizations.
- Identify and implement improvements to regulatory processes.
- Collaborate with cross-functional teams to gather necessary inputs for regulatory activities.
- Maintain documentation related to legislation, regulations, and guidelines.
- Monitor project timelines and report on progress.
Premarket Responsibilities:
- Facilitate global regulatory assessments to inform strategy.
- Assist in the product market release process.
- Compile materials for presubmission reports and submission packages.
- Organize documentation from preclinical and clinical studies for review.
Postmarket Responsibilities:
- Update and maintain regulatory files and archival systems.
- Prepare routine reports and communications for regulatory agencies.
- Support internal audits and inspections.
- Manage global product listings and facility registrations.
Qualifications:
- High school diploma required.
- Effective verbal and written communication skills.
- Ability to collaborate with departmental teams.
- Understanding of business and regulatory ethical standards.
- Strong attention to detail and ability to meet deadlines.
Preferred Qualifications:
- Associate's or Bachelor's degree in a relevant technical field.
- Experience in a regulated industry.
Additional Information
Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce. We encourage applications from all qualified individuals.
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