Abbott

Healthcare

SeniorManager,RegulatoryAffairs

$131–261k Alameda, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Senior Manager, Regulatory Affairs at Abbott. Skills: Regulatory Affairs, Product registration, Compliance. Recruit, coach and develop talent. Foster a diverse workplace”

Industry & Context.

Healthcare
Problems you'll solve

Problem-solving skills; Investigate and solve problems

Eligibility Requirements

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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