Senior Specialist Regulatory Affairs

Abbott Laboratories
Published
May 2, 2021
Location
Alameda, CA
Job Type

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 109,000 colleagues serve people in more than 160 countries.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, 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 location in Alameda, CA currently has an opportunity for a Senior Regulatory Affairs Specialist that is focused on exciting and ground-breaking work with Commercial teams on advertising & promotional review (ad promo).

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions.  The individual will be reviewing Ad Promo materials and identifying data needed, obtaining data and ensuring that they are effectively presented to substantiate claims. The individual will also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development.

WHAT YOU'LL DO:

  • Review promotional and advertising materials working with marketing to provide regulatory compliance input.
  • Assist with label development and review for compliance before release.
  • Assist in SOP development and review.
  • Provide regulatory input to product lifecycle planning.
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Assist in the development of regional regulatory strategy.
  • Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Determine and communicate submission and approval requirements.
  • Participate in risk benefit analysis for regulatory compliance.
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
  • Compile, prepare, review and submit regulatory submission to authorities.
  • Monitor impact of changing regulations on submission strategies.
  • Monitor applications under regulatory review.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
  • Assist compliance with product post marketing approval requirements.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Provide regulatory input for product recalls and recall communications.
     

EDUCATION AND EXPERIENCE YOU'LL BRING:

Bachelors’ degree with 3 years of regulatory affairs experience within medical devices or equivalent. Experience with review of labeling, promotional, and or advertising materials is desired. Additionally, experience with Ad Promo review, US Class II 510(k), or CE marked product is highly desired.  

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • A fast-paced work environment where your contribution is essential to success
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

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