Senior Regulatory Affairs Specialist (31029566)
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.
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
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
Drive for results
High level of attention to detail
Strong organizational skills
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.