Regulatory Affairs Project Manager

Abbott • CA

108d • $112,000 - $224,000

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. The opportunity is for a Regulatory Affairs Project Manager to join our Lingo team in Alameda, CA. The function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual will have department/group/site level influence and is generally recognized as an expert resource within the department.

Requirements

• Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• Minimum 4 years experience in a regulated industry (e.g., medical products, nutritionals).
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Regulatory knowledge of applicable product laws, submission/registration types and requirements, GxPs (GCPs, GLPs, GMPs).
• Strong communication skills, both verbal and written.
• Ability to manage projects and create project plans and timelines.

Nice To Haves

• Experience with LATAM regulatory parties.
• Fluent in Spanish.
• Advanced degree in Engineering, Sciences, or related discipline.
• Previous experience with Class III IDE submissions and/or PMA submissions or EU Technical Files.
• 8+ years of experience related to the preparation of FDA submissions (PMA, IDE, 510(k)).

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Develop new regulatory policies, processes and SOPs and train key personnel on them.
• Evaluate regulatory risks of division policies, processes, procedures.
• Provide regulatory input to product lifecycle planning.
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
• Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes.
• Assist in regulatory due diligence for potential and new acquisitions.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Determine submission and approval requirements.
• Identify emerging issues and monitor trade association positions for impact on company products.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
• Develop and mentor regulatory professionals.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and the Freedom 2 Save student debt program.
• Recognition as a great place to work in dozens of countries.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees