Abbott Associate Regulatory Affairs in Santa Clara, California
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.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Our location in Santa Clara, CA currently has an opportunity for an Associate Regulatory Affairs . As an individual contributor, the function of a Regulatory Operations Associate Specialist is to provide support for regulatory processes and procedures. The individual may execute tasks and exercise influence generally at the peer level. The individual will support a compliant state in the quality system by maintaining key process procedures current, collecting and reporting on metrics data, investigating potential nonconformities with the CAPA process and perform archival activities as directed.
WHAT YOU’LL DO
Strategic Planning and Project Coordination: Assist in quality system document development (WI, DOP, BUS level), review and initiation; Stay abreast of regulatory procedures and changes in regulatory climate and update department; Assist in monitoring and reporting project timelines; Respond to quality systems and audit information requests; and Monitor and utilize tracking and control systems.
Corrective and Preventive Action (CAPA): Own investigations in the CAPA process for potential or confirmed quality system nonconformities; develop resolution plan and implement corrective actions.
Product Approvals key process documents: Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations; Update and maintain paper/electronic document archival systems; Prepare legal documents for import/export, registrations, tenders/bids or other purposes; Support internal audits and inspections.
Job specific responsibilities may include: Monitoring metrics, reporting on metrics status, escalating to RA leadership as needed, Country specific regulatory support.
Individual coordinates and supports regulatory quality system activities, research regulations and guidance, and maintain and organize key information sources.
Individual works under general supervision, receives limited supervision on standard issues, and detailed instructions on new assignments.
Work is reviewed for soundness of judgment, overall adequacy and accuracy.
Influence/Leadership: Establish and cultivate a network of internal resources and peers to facilitate completion of tasks. Individual influence is typically exerted at the peer level.
Planning/Organization: Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
Decision Making/Impact: May exercise authority within pre-established limits and approval. Failure to achieve results can normally be overcome without serious effect on the business.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors Degree In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience
Minimum 2 years in a regulated industry (e.g., medical products, nutritionals).
Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
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).
Communication Skills or Ability to:
Communicate effectively verbally and in writing.
Learn to write and edit technical and quality system documents.
Work with cross-functional teams.
Work with people from various disciplines and cultures.
Cognitive Skills or Ability to:
Pay strong attention to detail.
Handle detailed tasks and prioritize them.
Think analytically and critically.
Review and analyze documentation.
Research and locate information on regulatory requirements and products.
Exercise judgment within defined procedures and practices to determine appropriate action.
Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment.
Apply business ethical standards.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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 (http://www.abbottbenefits.com/pages/candidate.aspx)
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com
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