Regulatory Affairs Specialist Role at Abbott USA
Looking for a career in regulatory affairs? Abbott is hiring a Regulatory Affairs Specialist II in Pleasanton, CA. Contribute to lifesaving heart failure solutions while advancing your career in a global healthcare leader.
Job Details:
- Job Title: Regulatory Affairs Specialist II – Heart Failure
- Location: Pleasanton, California, USA (On-site)
- Category: Regulatory Affairs
- Experience Required: Minimum 2 years in a regulated industry
- Employment Type: Full-time
- Industry: Medical Devices / Healthcare
- Preferred Qualification: Science, engineering, or medical-related degree
About Abbott:
Abbott is a global healthcare leader helping people live fully at all stages of life. Their portfolio includes diagnostics, medical devices, nutritionals, and branded generics. With 114,000 employees across 160+ countries, Abbott is committed to innovation, diversity, and career growth. Explore more regulatory affairs job offers.
Educational Requirements:
- Bachelor’s degree in science, medical technology, or related fields
- Master’s degree preferred (not mandatory)
- Relevant regulatory affairs certification is a plus
Key Responsibilities of Regulatory Affairs Specialist Role:
- Prepare FDA and international regulatory submissions to ensure compliance
- Review and approve engineering changes and documentation
- Analyze regulatory guidelines and conduct project assessments
- Maintain updated domestic and international regulatory requirements
- Interface with FDA and other regulatory agencies when needed
- Support product release processes, including GTS licenses
- Ensure compliance with company policies, Quality Management Systems (QMS), and Environmental Management Systems (EMS)
Skills Required for Regulatory Affairs Specialist Role:
- Strong verbal and written communication skills for technical documentation
- Ability to work with cross-functional teams and diverse cultures
- Attention to detail with analytical and critical thinking skills
- Excellent organization, multitasking, and project management abilities
- Knowledge of regulatory and business ethics
Benefits of the Regulatory Affairs Specialist Role:
- Career growth and development in a global company
- Health Investment Plan (HIP) PPO medical coverage
- Excellent retirement savings with high employer contribution
- Tuition reimbursement, student debt programs, and FreeU education benefits
- Recognition as a great place to work with inclusive and diverse culture
