Senior Regulatory Affairs Specialist - Lingo (on-site)

Abbott • Alameda, CA

3d • Onsite

About The Position

This Senior Regulatory Affairs Specialist will work on-site out of our Alameda, CA or Milpitas, CA locations in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be an important resource for the regulatory department to ensure efficient and compliant business processes. This is an exciting opportunity to work in the dynamic and evolving digital health space.

Requirements

• Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• Minimum 2 yrs. regulatory experience and/or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function
• 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area
• Ability to work effectively on cross-functional teams
• Must be able to juggle multiple and competing priorities
• Strong written, verbal, presentation, and organizational skills
• Working knowledge of FDA QSR
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Has a sound knowledge of a variety of alternatives and their impact on the business

Nice To Haves

• Advanced degree in Engineering, Sciences, or related discipline
• Previous experience with 510k / PMA submissions or class I / II exempt software devices
• Knowledge of insulin dosing products and diabetes management solutions
• Previous experience with SaMD, AI/ML, and other digital health technologies
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices
• Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred.

Responsibilities

• Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices
• Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance
• Assist in SOP development and review in support of "next-gen" product offerings
• Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
• Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval
• Assist in preparation and review of regulatory submission to authorities
• Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action
• Develop and refine design control procedures in collaboration with other stakeholders
• Utilize technical regulatory skills to propose strategies on complex issues
• Ensure compliance with product post marketing requirements
• Review product labeling to ensure compliance with relevant regulatory requirements
• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Influences middle management on technical or business solutions

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

What This Job Offers

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