Regulatory Affairs Specialist

Abbott Laboratories
Published
January 8, 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 107,000 colleagues serve people in more than 160 countries

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thatu2019s why weu2019re 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. Weu2019re revolutionizing the way people monitor their glucose levels with our new sensing technology.u00A0

Our location in Alameda, CA currently has an opportunity for a Regulatory Affairs Specialist that is focused on exciting new product registrations and existing products maintenance from a Canada and Latin America perspective, and also working with commercial on advertising & promotional review (ad promo). This is not a remote role and we are not providing relocation assistance.

WHAT YOU'LL DO
u00A0

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the regulatory department to ensure efficient and compliant business processes and environment.u00A0 The individual may execute tasks and play a consultative role by partnering across business functions.u00A0 The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products in Canada and Latin America.u00A0 The individual may prepare and submit documentation needed for registration or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development.

  • Assist in SOP development and review.

  • Experience with submission for NPI and on market products (510K and PMA).

  • 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 trade issues to anticipate regulatory obstacles.

  • Determine and communicate submission and approval requirements.

  • Compile, prepare, review and submit regulatory submission to authorities.

  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

  • Assist compliance with product post marketing approval requirements.

  • Assist with label development and review for compliance before release.

  • Review promotional and advertising materials working with marketing to provide regulatory compliance input.

EDUCATION AND EXPERIENCE YOU'LL BRING:

Bacheloru2019s degree (or equivalent) with 2 to 5 years of regulatory affairs experience within medical devices in Canada and Latin America. Experience with class III PMA products or CE marked product is preferred. Diagnostics and pharmaceuticals regulatory affairs experience is considered. Experience with review of labeling, promotional, and or advertising materials is desired. 510k and PMA submission highly desired. Software mobile app or cyber security product experience desired.

WHAT WE OFFER
u00A0

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:u00A0 www.abbottbenefits.com
u00A0

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.
u00A0

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Apply
Drop files here browse files ...

Related Jobs

Human Resources   Chicago, IL new
January 26, 2021
Software Developer   Arlington, VA new
January 26, 2021
Big Data Engineer - ETL   West Menlo Park, CA new
January 26, 2021
Electrical Engineer Intern   Fremont, CA new
January 26, 2021

Author: