Regulatory Affairs Manager – Lingo (on-site)

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 122,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
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
The Opportunity
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 Regulatory Affairs Manager to join our team 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.
What You’ll Work On
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.
May develop, monitor and appropriately adjust 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.
May lead Regulatory Affairs Ad & Promo SOP development and review.
Required Qualifications
Bachelor's Degree in a related field OR an equivalent combination of education and work experience
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. Note: Higher education may compensate for years of experience.
Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
Domestic and international regulatory guidelines, policies and regulations.
Lead functional groups in the development of relevant data to complete a regulatory submission.
Preferred Qualifications
Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Master’s or Ph.D. in a technical area
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.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$114,000.00 – $228,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:LNGO Lingo
LOCATION:United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf