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 122,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Structural Heart Business Mission: Why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
The Opportunity
As an individual contributor, the function of a Senior Regulatory Affairs Specialist (International) is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. This new team member, based on-site in Santa Clara, CA, may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
What You’ll Work On
Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Manage rest of world (all geographies outside the US and EU) submissions.
Strategic Planning: Assist in SOP development and review. 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 and update strategy based upon regulatory changes.
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. Participate in risk-benefit analysis for regulatory compliance.
Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval is important.
Post market: Maintain annual licenses, registrations, listings and patent information. Assist compliance with product post marketing approval requirements.
Review and approve advertising and promotional items to ensure regulatory compliance. Assess external…