Talent.com
Regulatory Affairs Manager – Heart Failure (on-site)

Regulatory Affairs Manager – Heart Failure (on-site)

Abbott LaboratoriesPleasanton, CA, United States
30+ days ago
Job type
  • Full-time
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

We are seeking a Regulatory Affairs Manager to join Abbott’s Heart Failure Division on-site in Pleasanton, CA.

As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department / group / site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

What You’ll Work On

Regulatory Knowledge / Skills

  • Anticipate regulatory obstacles and emerging issues.
  • Lead functional groups to complete a regulatory submission.
  • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Regulatory agency structure, processes and key personnel
  • Principles and requirements of applicable product laws
  • Principles and requirements of promotion, advertising and labeling
  • Interpret and apply regulatory requirements. Compile, prepare, review and submit regulatory submissions to authorities.
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process

    • Communication

  • Communicate effectively verbally and in writing.
  • Write and edit technical documents.
  • Communicate and work with people from various disciplines and cultures.
  • Negotiate internally and externally with regulatory agencies.
  • Plan and conduct meetings; Work with cross-functional teams.
  • Clearly explain and articulate Regulatory plans to Senior leaders.

    • Cognitive Skills

  • Define regulatory strategy
  • Perform risk assessment or analysis.
  • Juggle multiple and competing priorities.
  • Think analytically with good problem-solving skills.
  • Organize and track complex information.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Has broad knowledge of various technical alternatives and their potential impact on the business.
  • Exercise good and ethical judgment within policy and regulations.
  • Use in-depth knowledge of business functions and cross group dependencies / relationships.
  • Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
  • Lead functional groups in the development of relevant data to complete a regulatory submission.
  • Influencing others to a win / win resolution, appreciating all perspectives.

    • Leadership

  • Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
  • Provides leadership by communicating and providing guidance towards achieving business objectives.
  • Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
  • May lead a cross-functional or cross-divisional project team.
  • Provides technical leadership to business units.
  • Exercises judgment independently.

    • Required Qualifications

  • Bachelor’s Degree in a technical discipline or an equivalent combination of education and experience.
  • Minimum 6 years Regulatory experience
  • Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and / or experience with EU and other international medical device regulations and submissions.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and / or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to work independently with no oversight.
  • Ability to identify and solve problems in a strategic manner.
  • Ability to manage complex projects.
  • Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.

    • Preferred Qualifications

  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Advanced degree
  • 8 years’ Regulatory experience
  • Experience working in a broader enterprise / cross-division business unit model.
  • Demonstrated experience at a supervisory / managerial level.
  • 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 elevate issues as appropriate.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

    • 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

    The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.

    #J-18808-Ljbffr

    Create a job alert for this search

    Heart Failure • Pleasanton, CA, United States

    Related jobs
    • Promoted
    Regulatory Affairs Director

    Regulatory Affairs Director

    Pano AISan Francisco, CA, United States
    Full-time
    Every minute matters in fire response.As climate change amplifies the intensity of wildfires—​with longer fire seasons, drier fuels, and faster winds—​new ignitions spread faster and put more commu...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Revolution MedicinesRedwood City, CA, US
    Full-time
    Associate Director Of Regulatory Affairs.Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addict...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Katalyst Healthcares & Life SciencesSan Francisco, CA, US
    Full-time
    Responsibilities : Develop and execute U.IDE, 510(k), De Novo) and post-market requirements.Serve as the primary point of contact with the U. Food and Drug Administration (FDA) and their regulatory a...Show moreLast updated: 3 days ago
    • Promoted
    Senior Director Regulatory Affairs

    Senior Director Regulatory Affairs

    EPM ScientificSan Francisco County, CA, United States
    Full-time
    The Senior Director will lead global regulatory strategy and operations across development pipeline.Developing and executing regulatory strategies. Overseeing submissions : INDs, CTAs, NDAs, BLAs, MA...Show moreLast updated: 15 days ago
    • Promoted
    Regulatory Affairs CMC Director

    Regulatory Affairs CMC Director

    ExelixisAlameda, CA, United States
    Full-time
    Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects.Develop strategic approaches to enable succesful Health Authority submissions and communicatio...Show moreLast updated: 30+ days ago
    • Promoted
    Director / Senior Director, Regulatory Affairs (Clinical & CMC)

    Director / Senior Director, Regulatory Affairs (Clinical & CMC)

    Valid8 Financial, Inc.San Francisco, CA, United States
    Full-time
    Director / Senior Director, Regulatory Affairs (Clinical & CMC).Director / Senior Director, Regulatory Affairs.This individual will oversee both Clinical and CMC regulatory functions, providing strat...Show moreLast updated: 30+ days ago
    • Promoted
    Director_Sr. Director, Regulatory Affairs

    Director_Sr. Director, Regulatory Affairs

    Abdera Therapeutics Inc.San Francisco, CA, United States
    Full-time
    We have built a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy tissue. Using this platform we are rapidl...Show moreLast updated: 1 day ago
    • Promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Katalyst CROSan Francisco, CA, United States
    Full-time
    Quality Assurance & Regulatory Affairs Manager, San Francisco, CA.IDE, 510(k), De Novo) and post-market requirements.Serve as the primary point of contact with the U. Food and Drug Administration (F...Show moreLast updated: 3 days ago
    • Promoted
    Manager, Regulatory Affairs

    Manager, Regulatory Affairs

    Gilead Sciences, Inc.Foster City, CA, United States
    Full-time +1
    At Gilead, we’re creating a healthier world for all people.For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapi...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Regulatory Affairs

    Director, Regulatory Affairs

    SepternaSan Francisco, CA, United States
    Full-time
    Septerna – Director of Regulatory Affairs.Septerna is a biotechnology company based in South San Francisco, CA, focused on developing life‑changing medicines. We aim to become the industry‑leading G...Show moreLast updated: 6 days ago
    • Promoted
    Associate Director, Regulatory Affairs (Remote)

    Associate Director, Regulatory Affairs (Remote)

    BioSpacePalo Alto, CA, United States
    Remote
    Full-time
    Associate Director, Regulatory Affairs (Remote).Jazz Pharmaceuticals is a global biopharma company dedicated to developing life‑changing medicines for serious diseases. This role is essential to the...Show moreLast updated: 10 days ago
    • Promoted
    Associate Director, Regulatory Affairs - Virology

    Associate Director, Regulatory Affairs - Virology

    Gilead Sciences, Inc.Foster City, CA, US
    Full-time
    Associate Director, Regulatory Affairs - Virology At Gilead, we're creating a healthier world for all people.For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 an...Show moreLast updated: 1 day ago
    • Promoted
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Olema OncologySan Francisco, CA, United States
    Full-time
    Olema Oncology is dedicated to developing better medicines for breast cancer and beyond.Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in dev...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Regulatory Operations (Systems)

    Director, Regulatory Operations (Systems)

    Revolution MedicinesRedwood City, CA, United States
    Full-time
    The Director of Regulatory Information Management (RIM) will partner closely with the Senior Director and Head of Regulatory Operations and Planning to build, lead, and scale Revolution Medicines’ ...Show moreLast updated: 30+ days ago
    Director_Sr. Director, Regulatory Affairs

    Director_Sr. Director, Regulatory Affairs

    Abdera TherapeuticsSouth San Francisco, CA, US
    Full-time
    Quick Apply
    Who we are Abdera Therapeutics Inc.The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing hea...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Regulatory Strategy

    Director, Regulatory Strategy

    ExelixisAlameda, CA, United States
    Full-time
    Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements.Ensures timely preparat...Show moreLast updated: 18 days ago
    • Promoted
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    BioSpaceSan Francisco, CA, United States
    Full-time
    Location : Mission Bay, San Francisco, CA – full-time, on‑site.GABAeron takes a novel approach that combines precision medicine (using genetic information for patient stratification) with regenerati...Show moreLast updated: 1 day ago
    • Promoted
    Associate Director, Regulatory Affairs - Oncology

    Associate Director, Regulatory Affairs - Oncology

    Gilead Sciences, Inc.Foster City, CA, United States
    Full-time
    Regulatory Affairs or other relevant industry experience.Degree in a scientific field is preferred.Responsible for preparing and / or overseeing the preparation of technically complex regulatory subm...Show moreLast updated: 30+ days ago