Regulatory Affairs Specialist

Abbott Laboratories
Published
November 7, 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. 

We are presently hiring for a U.S. Regulatory Affairs Specialist, Post-Market at our Division HQs location in Alameda, CA. This Regulatory Affairs role is focused on exciting and ground-breaking work with U.S. Commercial Teams focused on Marketing Communications, Advertising and Promotional review (ad promo) strategies.

WHAT YOU'LL DO:

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and partner across business functions. 

The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions.
This is a broad scoped position with strong opportunity for growth and career development based on performance.

Core Job Responsibilities:

  • Review and analyze labeling, promotional and advertising materials while working with Marketing to provide regulatory compliance input.

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

  • Assist in Regulatory Affairs SOP development and review.

  • Assist with submission for NPI and on market products (510K, PMA and Health Canada submissions).

  • Provide regulatory input to product lifecycle planning.

  • 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.

  • 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.

EDUCATION AND EXPERIENCE YOU'LL BRING:

  • Bachelor’s degree is required - OR - an equivalent combination of education and work experience

  • Must have a minimum of 2 years experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

  • 1+ year of Regulatory Affairs experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired.  

  • Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel;  Principles and requirements of applicable product laws;  Submission/registration types and requirements;  GxPs (GCPs, GLPs, GMPs);  Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations;  Ethical guidelines of the regulatory profession, clinical research and regulatory process.

  • Communicate effectively verbally and in writing.  Communicate with diverse audiences and personnel.  Write and edit technical documents.

  • Work with cross-functional teams.  Work with people from various disciplines and cultures.

  • Write and edit technical documents.  

  • Negotiate internally.  

  • Pay strong attention to detail.

  • Manage projects. Create project plans and timelines.

  • Think analytically and critically.

  • Organize and track complex information.

  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
     

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

Apply
Drop files here browse files ...

Related Jobs

November 7, 2021

Author: