Regulatory Affairs Specialist II – Lingo (on-site)

Abbott • Alameda, CA

12d • $81,500 - $141,300 • Onsite

About The Position

Abbott is seeking an experienced Regulatory Affairs Specialist II to join its Lingo team on-site in Alameda, California. The role performs specialized regulatory work, including evaluating, preparing, and submitting documentation for regulatory registration to ensure products and procedures comply with agency requirements and to support product market entry. Lingo is a biosensing technology that tracks biomarkers such as glucose, ketones, and lactate to help users make decisions about their health and nutrition.

The position prepares regulatory submissions for medical devices; reviews engineering change orders and project documentation; evaluates regulatory guidelines and communications; maintains current domestic and international medical-device regulatory requirements and submission records; and supports compliant, timely product releases. It also works with marketing to review advertising and promotional materials and supports company quality, environmental, and other regulatory initiatives. The role requires compliance with FDA and international regulations, company policies, procedures, processes, and assignments, as well as constructive collaboration with employees, customers, contractors, and vendors.

Requirements

• Bachelor’s degree or equivalent.
• 2–3 years of experience in a regulated industry, such as medical products or nutritionals. Regulatory experience is preferred; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may also be considered.
• Higher education may compensate for years of experience.
• Ability to work in a team environment and complete projects in a fast-paced, matrixed environment.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.

Nice To Haves

• Bachelor’s degree in a science field such as biology, chemistry, or microbiology; mathematics; engineering; or a medical field.
• Master’s degree in Regulatory Affairs.
• Regulatory experience with capital equipment, including software, firmware, graphical user interfaces, and associated hardware.
• Certification is a plus, such as RAC from the Regulatory Affairs Professionals Society.

Responsibilities

• Prepare regulatory submissions for devices to achieve departmental and organizational objectives.
• Review and approve engineering change orders for protocols, reports, specifications, and other project documentation supporting new product development and sustaining activities.
• Serve as a regulatory representative by reviewing and analyzing applicable regulatory guidelines.
• Review and evaluate communications to ensure they contain necessary detail and comply with applicable FDA and international regulatory standards.
• Maintain current domestic and international medical-device regulations and submission requirements in regulatory databases and file systems; distribute information about new or modified requirements to appropriate personnel when requested.
• Support product release by collaborating with the Regulatory Operations team and ensuring products are released compliantly and on time.
• Collaborate with the marketing team to review and approve advertising and promotional materials.
• Support company initiatives and requirements related to Quality Management Systems, Environmental Management Systems, and other regulatory matters.
• Comply with FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities as assigned.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level