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Job Details


Abbott

Senior Regulatory Affairs Specialist (31029566)

Pharmaceuticals

All

Yearly

Full Time

No

Pomona, California, United States

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 113,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Senior Regulatory Affairs Specialist is within our Toxicology Business Unit located in Pomona, CA or Remote. This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

  • Provides regulatory support for commercial diagnostic products

  • Develops regulatory strategies to achieve clearance/approval internationally (outside United States)

  • Perform regulatory assessments on changes implemented on a 510(k) cleared or CE mark product.

  • Compiles and publishes all material required for submissions, license renewals, and annual registrations

  • Works with governmental regulatory agencies and other third-party accrediting bodies

  • Maintains approvals/licenses/authorizations for existing marketing authorizations

  • Adds and maintains information contained in the Global Regulatory Information Database

  • Provides recommendations on labeling, for regulatory compliance

  • Develops internal procedures and tools

  • Conducts informational or training sessions for stakeholders

  • Organizes and maintains hard copy and electronic department files

  • Keeps informed of global regulatory information

  • Carries out duties in compliance with established business policies

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

  • Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

  • Performs other duties and projects as assigned

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

  • Bachelor’s degree (BS/BA) in a scientific field

  • 2-4 years of experience in a regulated industry

  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

  • Must be detail-orientated, self-motivated and available for flexible scheduling

  • Strong written and verbal communication, problem solving and motivational skills

  • Remote may be considered based on candidate experience

  • MDR/IVDR/technical file experience

PREFERRED QUALIFICATIONS:

  • Minimum 2 years of experience in Medical device Regulatory Affairs

  • 2-3 years in an IVD or medical device manufacturing environment

  • 510k submission experience is a plus.

  • Technical file creation and maintenance experience

  • Strong knowledge of US and Foreign regulations

  • Able to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributor

  • Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling

  • Remote work may be considered based on candidate experience

COMPETENCIES:

  • Drive for results

  • High level of attention to detail

  • Teamwork

  • Communication

  • Strong organizational skills

  • Initiative

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.