Regulatory Affairs Manager

Abbott Laboratories
Published
October 3, 2020
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 103,000 colleagues serve people in more than 160 countries.

Our location in Alameda, CA currently has an opportunity for a Regulatory Affairs Manager responsible for providing advertising and promotion strategies by collaborating with cross-functional professionals to develop and execute promotional campaigns, and also providing CALA strategies for initial product concepts and input to senior regulatory management, while assisting in multi-country regulatory assessments.

WHAT YOU’LL DO 

Ad Promo:

  • Review promotional, corporate and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
  • Define regulatory advertising objectives to ensure campaigns are effective, economical, and appropriate for their intended audience.
  • Liaise with managers in sales, marketing, and brand management to review campaigns that will help them achieve their sales goals.
  • Align with the organization's overall advertising and promotions strategy.
  • Contribute to the review of sales strategies for a product, service, or market segment that align with the organization's vision and its current and long-term business objectives.
  • Must have in-depth knowledge of commercial regulatory requirements associated with Advertising and Promotion of medical devices.
  • Must be capable of developing and implementing regulatory strategy and working closely with various stakeholders.

Premarket Submissions:

  • 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 and update internal stakeholders
  • Monitor applications under regulatory review
  • Communicate application progress to internal stakeholders
  • Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Provide strategic input and technical guidance on regulatory requirements to development teams
  • Manage and execute pre-approval compliance activities
  • Post market Submissions:
  • Oversee processes involved with maintaining annual licenses, registrations and listings  
  • Ensure compliance with product post marketing approval requirements
  • Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
  • Report adverse events to regulatory agencies and internal stakeholders
  • Provide regulatory input for product recalls and recall communications

EDUCATION AND EXPERIENCE YOU’LL BRING 

Minimum Education

Bachelor's degree (preferably in engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence; an advanced degree (such as a Master's or MBA) is preferred; post-graduate education may contribute toward the desired years of experience.

Minimum Experience / Training Required

4-5 years experience in advertisement and promotion review, with 2-3 years of experience in
regulatory submissions.

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 safety is our priority (Include for Manufacturing roles only) 
  • Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only) 
  • Training and career development, with on boarding 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  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal. 

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