Senior Manager, Regulatory Affairs - Lingo (on-site)

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• 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
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

We are recruiting for a Senior Regulatory Affairs Manager to join our team on-site in Alameda, CA.  In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide.

• Recruits, coaches and develops organizational talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Creates an entrepreneurial environment.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May manage and coach a team of regulatory employees.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develops, monitors and appropriately adjusts the annual budget for department(s).
• Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
• Assess proposed regulations and communicate new requirements to the organization.
• Lead the RA process for Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
• Assist with promotional content development and review for compliance before distribution.
• Lead Regulatory Affairs Ad & Promo SOP development and review.

• Bachelor’s Degree in a related field or an equivalent combination of education and experience
• Minimum 9 years related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or unit.
• Monitors company-wide indicators such as market share and profitability.
• Monitors external environment in area of technical or professional responsibility.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
• Facilitates others' participation in the continuous improvement program.
• Investigates and solves problems that impact work processes and personnel within or across units or departments.
• Develops and communicates a vision for the organizational unit assigned.

• Master’s degree
• Submission / registration types and requirements
• Experience working with Class III implantable devices.
• Effective verbal and written communication with diverse audience and team.
• Analytical thinking with good problem-solving skills.
• Experience managing and leading a team.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Must be able to lead and manage multiple and competing priorities and manage programs.
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and escalate issues as appropriate.

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