Abbott
Healthcare
SeniorManager,RegulatoryAffairs
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager, Regulatory Affairs at Abbott. Skills: Regulatory Affairs, Product registration, Compliance. Recruit, coach and develop talent. Foster a diverse workplace”
Industry & Context.
Problem-solving skills; Investigate and solve problems
10% travel
What They're Looking For.
Must Have
Bachelor's Degree in related field, Minimum 9 years related work experience
Nice to Have
Master's degree, Submission / registration types and requirements, Experience with Class III implantable devices, Experience managing and leading a team, Certification is a plus, Working knowledge of QSR, ISO, and EN standards, Working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies, Experience with medical device software requirements and software regulations
What You'll Do.
coach and develop talent
Foster a diverse workplace
Create an entrepreneurial environment
Provide direction to specialists
Manage and coach regulatory employees
Keep vision and values at forefront
Demonstrate effective change leadership
Build strategic partnerships
Develop and execute policies
Monitor compliance with company policies
Make decisions regarding work processes
Develop and monitor annual budget
Develop regulatory strategies
Develop approval schedules
Develop submission standards
Assess proposed regulations
Communicate new requirements
Lead RA process for review
Analyze labeling materials
Analyze advertising materials
Analyze promotional materials
Provide regulatory strategy input
Provide compliance input
Assist with promotional content development
Review promotional content for compliance
Lead RA Ad & Promo SOP development
Lead RA Ad & Promo SOP review
How You'll Work.
Team & Collaboration
Marketing teams; Cross-functional teams
Communication Scope
Verbal communication; Written communication
Process & Methodology
Program management
Full Job Description
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 115,000 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](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 fut
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