Regulatory Affairs Specialist II – Lingo (on-site)

Abbott Laboratories • Alameda, CA

11d • $81,500 - $141,300 • Onsite

About The Position

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join its Lingo team on-site in Alameda, California. 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 specialist performs specialized regulatory assignments and analyses, evaluates and prepares regulatory registration documentation, and submits materials to help ensure products and procedures comply with regulatory agency specifications. The role supports regulatory activities required for product market entry.

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 be considered.
• Higher education may compensate for years of experience.
• Ability to work within a team and accomplish 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 science (such as biology, chemistry, or microbiology), math, 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.
• Act as a regulatory representative responsible for reviewing and analyzing applicable regulatory guidelines.
• Review and evaluate communications to ensure they convey necessary details and comply with applicable regulatory standards, including FDA and worldwide agency standards, for international affiliates.
• Maintain current domestic and international medical device regulations and world-wide submission requirements in regulatory submission 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 compliant, timely product release.
• Collaborate with the marketing team to review and approve advertising and promotional materials.
• Support company initiatives and requirements relating to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with FDA regulations, international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees at all levels, 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