Regulatory Affairs Specialist II – Lingo (on-site)

Abbott • Alameda, CA

10d • Onsite

About The Position

Abbott is seeking an experienced Regulatory Affairs Specialist II to join the Lingo team on-site in Alameda, California. The role performs specialized work and analyses involving the evaluation, preparation, and submission of regulatory documentation, ensuring products and procedures comply with regulatory agency specifications and supporting regulatory activities needed for product market entry.

The specialist prepares device regulatory submissions, reviews and approves engineering change orders and project documentation, monitors applicable domestic and international medical device regulations, and supports compliant and timely product releases. The role also reviews communications and promotional materials for regulatory compliance and supports company quality, environmental, and other regulatory systems. It requires collaboration across teams and maintaining effective communication 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, though 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, 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 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 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 FDA and other worldwide regulatory standards.
• Maintain current domestic and international medical device regulations and submission requirements in regulatory submission databases and file systems.
• Distribute information about new or modified regulations and requirements to appropriate personnel when requested.
• Support product release by collaborating with the Regulatory Operations team and helping ensure products are released compliantly and on time.
• Collaborate with the marketing team to review and approve advertising and promotional materials.
• Support company initiatives related to Quality Management Systems, Environmental Management Systems, and other regulatory requirements.
• Comply with FDA and international regulations, 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 a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, providing an affordable and convenient path to earning a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

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