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Associate Director, Regulatory Affairs – US New Product Introductions & On-Market Changes (on-site)

Location United States - California - Alameda Category Regulatory Affairs
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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 114,000 colleagues serve people in more than 160 countries.

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

This Associate Director Regulatory Affairs – US New Product Introduction and On-Market Changes will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes.

This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs. Projects include our continuous glucose-ketone monitoring system that will continuously monitor both glucose and ketone levels in one sensor. The role will also include responsibilities for regulatory support for on-market change management and manufacturing sites. The individual has department level influence with experience in US submissions (PMA / 510k / DeNovo), people management and development, and is generally recognized as an expert resource both within Abbott and externally.  The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop regulatory submission strategy, and provide executive management with regulatory metrics/information.

WHAT YOU’LL DO

  • Develop global regulatory strategies for product development and planning throughout the product lifecycle.
  • Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
  • Provide technical leadership and strategic input on complex issues and to business units.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
  • Develop and communicate a vision for the organizational unit assigned.
  • Create project plans and timelines.
  • Lead functional groups in the development of relevant data to complete a regulatory submission.
  • Write and edit technical documents.
  • Recruit, develop and manage regulatory professionals.
  • Evaluate performance of and assists in career development planning for subordinates.
  • Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
  • Negotiate with regulatory authorities during the development and review process to ensure submission approval.
  • Review and approve labeling to ensure compliance.
  • Monitor emerging issues and identify solutions.
  • Negotiate internally and externally with regulatory agencies.
  • Identify need for new regulatory policies, processes and SOPs and approve them.
  • Evaluate regulatory risks of corporate policies.
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
  • Ensure compliance with product post-marketing approval requirements.
  • Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
  • Actively contribute to the development and functioning of the crisis/issue management program
  • Analyze product-associated problems and develop proposals for solutions.
  • Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
  • Provide regulatory input for product recalls and recall communications.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • Bachelor's degree
  • 5-7 years’ experience in a regulated industry (e.g., medical products).
  • 5-7 years’ 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.

Preferred

  • Bachelor's degree in computer science, math, engineering, or medical fields.
  • M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
  • Previous experience with 510k / PMA / DeNovo submissions or class I / II exempt software devices
  • 7-10 years’ experience in a regulated industry. Regulatory area is preferred but may consider software or systems research and development, or related area.
  • Ability to work effectively on cross-functional teams.
  • Must be able to juggle multiple and competing priorities.
  • Strong written, verbal, presentation, and organizational skills.
  • Experience with FDA QSR.
  • Has a sound knowledge of a variety of alternatives and their impact on the business.

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 $146,700.00 – $293,300.00. In specific locations, the pay range may vary from the range posted.

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Job Id 31091726 Location United States - California - Alameda Medical surveillance No Division ADC Diabetes Care Travel Yes, 10 % of the Time Additional Location 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)

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