Principal Regulatory Affairs Specialist - Heart Failure (on-site)

in Pleasanton, CA

Principal Regulatory Affairs Specialist - Heart Failure (on-site) Job

Job Description Job Attributes+

  • Job ID

    31068401-1

  • Req #

    ABLAUS31068401ENUSEXTERNAL

  • Job Location

    Pleasanton, CA, US

  • Job Category

    Regulatory Affairs

  • Job Type

    Full time

  • Travel

    Yes, 5 % of the Time

  • Schedule

    40 hours per week

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
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • 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 Principal Regulatory Affairs Specialist to join Abbott’s Heart Failure Division.

As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.

What You’ll Work On

  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
  • Develops global regulatory strategies for new and modified products.
  • Prepares and submits PMA and IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applications.
  • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
  • Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
  • Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Reviews protocols and reports to support regulatory submissions.
  • Creates, reviews and approves engineering change requests.
  • Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.

Required Qualifications

  • Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
  • Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
  • Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).

Preferred Qualifications

  • 5-7 years’ experience in a regulated industry with a minimum of 3 of those years directly related to Class III Medical Devices.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Ability to work effectively on project teams.
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Strong written, verbal, presentation, and organizational skills.
  • Strong analytical and problem-solving skills.
  • 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.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 $83,000.00 – $166,000.00. In specific locations, the pay range may vary from the range posted.

Job Skills

  • qsr
  • regulatory affairs
  • regulatory compliance
  • product development
  • iso 13485
  • 21 cfr
  • gts
  • diagnostics
  • quality management systems
  • quality management
  • quality system support
  • license maintenance
  • international product registration

Additional Information

Who We Are

PUT YOUR TALENTS TO WORK

Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.

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